Quality & Compliance Manager Resume Sample
Elroy Mante
6039 Frederik Springs,
Dallas,
TX
+1 (555) 687 0808
Work Experience
Quality Compliance Manager
03/2017
-
PRESENT
Phoenix, AZ
- Excellent attention to detail but can also put thinking into perspective (see the bigger picture)
- Support the delivery and oversight of the quality compliance services at multiple client sites
- Monitor and ensure CBRE is compliant with all regulatory and quality requirements for the scope of work that CBRE performs at each of the sites
- Supervises staff and is responsible for hiring, training and managing performance of the staff who deliver quality compliance services
- Execute quality compliance team activities that support the quality compliance contractual obligations
- Interface with CBRE management and client management to identify applicable regulatory and compliance requirements and ensure accurate understanding of those requirements between CBRE and the client
- Interface with the site management to ensure quality compliance services are delivered to applicable regulatory requirements, contractual requirements and client satisfaction
- Manage vendors providing quality compliance support
- Identify any quality, compliance and contractual issues and communicate them to the appropriate CBRE and customer management teams. Work with those teams to resolve any identified issues
Quality & Compliance Manager
06/2010
-
12/2016
San Francisco, CA
- Support any quality investigations and Corrective Action/Preventative Action (CAPA) plans for any work falling under the scope of CBRE responsibility or as requested by the customer to support their operations
- The role of CFDA in the licensing of Medicines/Medical Devices/Health Food/Cosmetics and as the competent authority
- Coordinates and conducts routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards and other applicable requirements[i.e. QMS, QSIT, Combination Products, Regulatory requirements; PAL, TGA, Notified Bodies, etc.]
- Practices and adheres to HCA’s “Code of Conduct” philosophy and “Mission and Value Statement”
- The role of Regulatory Authorities in the licensing of Medicines/Medical Devices/Health Food/Cosmetics
- Oversee the quality/compliance engineering program of the building systems including: process equipment, EMS, utilities, and support services such as sanitization, pest control, garments, and related services such as temperature controls systems, and critical environments
- Coordinate with Campus Manager, Chief Engineer, Shift Leads and site staff to resource and implement programs
- Maintain all infrastructure and compliance documentation for the building including up-to-date building drawings, and single-lines as well as documentation mandated for the purpose of maintaining regulatory compliance with Federal, State or Local law
Quality / Compliance Manager
08/2004
-
02/2010
Philadelphia, PA
- Provides facility specific quality assurance assistance to the project management team as needed or requested
- Provide support to the site staff with the coordination and scheduling of maintenance activities
- Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems
- Develop and deploy full set of Quality processes and tools that enable the organisation to ensure our products and services are fit for purpose, consistent and meet external requirements (customers and regulations) and internal quality standards
- Evaluate and advise on the performance of the quality management system and products against set standards and specifications
- Provide clear information and recommendations to top management for driving superior quality
- Drive continual improvement by providing tools and techniques to enable others to achieve the product quality targets
- Develop and keep updated BAT evaluation and reporting quality tools (e.g. FPI, Quality dashboard)
- Provide support to the Global Quality community and the entire organization in promoting the quality culture
Education
Illinois State University
2000 - 2004
Bachelor's Degree in Food Science
Professional Skills
- Strong knowledge of plant programs, quality systems, auditing experience and strong written and oral communication skills
- Strong analytical and critical thinking skills and experience in utilizing work processing, spreadsheets, and clinical systems/databases required
- Excellent organizational skills and strong ability to handle multiple projects while successfully meeting deadline
- Proven process management skills (ITIL & Lean Six Sigma) and Lean Six Sigma experience
- Effective communicator with excellent relationship building & interpersonal skills
- Work independently, and effectively in a team environment, with proven experience as a team player within international project teams
- Excellent written & oral communication skills in English (and any local language as appropriate)
How to write Quality & Compliance Manager Resume
Quality & Compliance Manager role is responsible for interpersonal, leadership, english, organization, training, languages, reliability, integration, auditing, purchasing.
To write great resume for quality & compliance manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality & Compliance Manager Resume
The section contact information is important in your quality & compliance manager resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Quality & Compliance Manager Resume
The section work experience is an essential part of your quality & compliance manager resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous quality & compliance manager responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality & compliance manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality & Compliance Manager resume experience can include:
- Outstanding communication skills – oral and written
- Communicate effectively with technical, quality assurance and other personnel
- In concert with manufacturing and Marketing Company Quality organizations, establishes and executes Cold Chain processes including validation
- Experience of building, setting and revising Global Quality Standards / SOP's
- Experience of hosting and conducting audits and quality reviews
- Previous assignment experience promoting or requiring regional or global perspective desirable
Education on a Quality & Compliance Manager Resume
Make sure to make education a priority on your quality & compliance manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality & compliance manager experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Quality & Compliance Manager Resume
When listing skills on your quality & compliance manager resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical quality & compliance manager skills:
- Strong leadership skills including developing and motivating the team
- High credibility and reliability – strong interpersonal skills
- Strong interpersonal communication and coaching skills
- Have a strong background in either Quality Control or Estate Agency; the ability to demonstrate experience in both fields would be an advantage
- Influencing skills, especially of SMEs and senior stakeholders
- Strong working knowledge in PCs (experienced in Excel, Word, PowerPoint, Outlook and SAP) and in Quality Systems
List of Typical Experience For a Quality & Compliance Manager Resume
1
Experience For Quality Compliance Manager Resume
- Cooperates with quality and logistic functions for certification of Good Importation and Good Distribution Practices
- Excellent interpersonal skills – Builds and maintains relationships inside and outside the organization
- Prior experience in quality, compliance or regulatory operations in (GxP) regulated environments
- Responsible for developing the Supplier Quality Assurance framework at global level to ensure a good basis for the materials quality standards
- Ensures effective partnership with customers (QA agreements) to ensure alignment of PLS quality plan, GxP’s and pharmacovigilance processes
2
Experience For Quality & Compliance Manager UK & Ireland Resume
- To work imaginatively to make use of the tools and abilities of the team to execute deployment of the policies and procedures in an effective manner
- Exhibits good business sense, makes sound and timely scientific and business decisions
- Auditing – Ensure a Local process is in place to support Audit activities as necessary, including Health Authorities Inspections
- Licensing- Responsible for submission, renewal and oversight of state licensing as applicable
- Provide expertise and guidance to collaborating departments in interpreting and implementing government and agency guidelines to assure GxP compliance
- Support the Quality Planning Process and risk profiling activity & mitigation approaches during the study life-cycle
- Leverage the knowledge/technologies/capabilities from internal/external networks aligned with the Quality Strategy to extend the quality capabilities of our supply chain
3
Experience For Quality / Compliance Manager Resume
- Friendly, inclusive working environment
- Develop, implement, and execute the GxP compliance auditing program to ensure the fulfillment of regulatory requirements
- Review and monitor Corrective Action Plans identified internally and/or externally and assist in root cause analysis and formulating responses
- Knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools
- Acts in a balanced and ethical manner when dealing in gray areas of regulation
- Competitive compensation package, further reward schemes
- Crystal clear Strategy and Vision
- Cafeteria, car, laptop/IPad, mobile
- Develop and execute risk based quality assurance strategies to support the Global Clinical Operations activities, which include assessment / audit planning, conduct, documentation and follow up of planned activities
4
Experience For CLS Quality & Compliance Manager Resume
- Maintain knowledge of FDA and other regulatory agencies’ (e.g., European agencies) activities, regulations and guidelines relevant to Clinical Affairs
- Monitor relevant agency compliance rulings and communications
- Lead role in supplier/vendor qualification and compliance oversight process
- Support regulatory inspections of Sponsor, GCP sites and GxP vendors
- Support the management of quality systems & continuous improvement
- Interact and develop relationships with vendors’ quality leaders through audits, project teams, and established one-on-one relationships
- Write GxP Quality SOPs in support of the Clinical Quality SystemsEnsure compliance with corporate policies and procedures as well as US healthcare laws and regulations through ongoing assessments during the conduct of studies
5
Experience For Clinical Quality & Compliance Manager Resume
- Advanced knowledge of and experience of with all regulations, and relevant standards (e.g., FDA, ISO, MDR, IVDR GDPR)
- Produce training material and conduct training sessions regarding compliance to policies, procedures, standards and regulations
- Identify additional capacity needs in the audit activity, assist in sourcing, and train incumbents on internal SOP’s related to the audit program
- Development and maintenance of written internal procedures for clinical assessments and associated templates
- Participation in external committees (e.g., AdvaMed) as requested
- Manage all aspects of the business’ compliance with the Consumer Product Safety Act as well as adherence to foreign country regulatory laws related to products and distribution
- Manage seasonal product compliance plans and schedules to meet Vera Bradley’s collection release dates
- Maintain all required documentation involved in company’s Social Compliance Program and related vendor certification
- Determine supplier’s conformance status; implement appropriate corrective action plans as necessary
6
Experience For Senior Quality Compliance Manager Resume
- Proven work experience in the area consumer products compliance and product certification. Could be from areas like food, pharma or aviation. Experience from the toy business is an advantage
- Ensuring returned product is dispositioned according to predefined agreements with Operating Company, Franchise, or Marketing Co.
- Maintains ongoing oversight of the facilities departments’ regulatory and quality compliance
- Plan and forecast QA team workload to insure auditing requirements are met in a timely manner for all business units
- Readiness to travel on a short notice to other parts of Asia
- Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed
7
Experience For Global Quality Compliance Manager Resume
- Quality oversight of pick/pack/and ship operations, including trending of pick/pack/ and ship errors
- Inventory Quality management, including lot reconciliation within the DC
- Quality oversight of Quarantine/hold/stop-ship/recall processes within the Logistics Center
- Responsible to ensure all CAPA are entered into the AQWA system, and tracked to closure, assessing effectiveness of Corrective and Preventive Actions (CAPA’s) as required
- To keep up to date with an array of changing and evolving legislation that could impact policies and procedures
- To build a network of key stakeholders in the business to gain approval
- Facilitate SMEs towards the production of high standard policies and procedures
- To manage the above to tight deadlines
8
Experience For Principal Clinical Quality & Compliance Manager Resume
- Lead with project management mindset the different Employee Experience, Supplier Performance and Patient Safety projects with the SGM regions to ensure effective execution
- Lead and execute the strategic Service Tools Planning & Optimization initiative across SGM while aligning with Customer Operations and Productivity teams to drive the right execution and ensure compliance metrics are 100% met for tools management
- Working with other regions, global and modality teams to bring available/applicable solutions and
- Develop and maintain QA call monitoring processes and compliance standards for all contact centers’ departments and functions
- Manage a team of specialists who monitor and evaluate customer call interactions to assess trends and recommend coaching and training initiatives aligned with key departmental goals and objectives
9
Experience For Service Growth Markets Service Quality & Compliance Manager Resume
- Conduct regular quality calibrations with department leadership to assure consistency
- Maintain collaborative relationships with leadership from all internal and external partners to assure consistency in quality processes and adherence to processes and procedures
- Generate regular quality reports for departmental leadership indicating trends, areas of opportunity, and insight into business objectives and special projects
- Internal = Regional and Global Quality Functions, Local, Regional and Global GRS teams and BMSA commercial organization including Operations, Brand teams, customer service team
- External = Government Regulatory Authorities and Third Party Suppliers and Vendors
- Maintain a Fit-For-Purpose QMS:Report level of compliance of local QMS versus Global Policies and GMP regularly to Regional Quality Director, GM’s, SVP’s, EVP’s and drive closure of gaps to maintain
- Responsible for initial compliance assessment and approval of Distribution Centres & Embellishers handling RB Products
- Support the preparation of Technical Agreements (TAs) and Specifications for Carriers, Distributors & Embellishers – ensure all quality expectations are included (e.g. change management, product handling, product release, defining roles and responsibilities)
- A natural leader, who thrives on working with people and helping others achieve their potential
10
Experience For Imex Quality Compliance Manager Resume
- Assist with self-inspections and ensuing corrective/preventive actions
- Lead Quality Update meetings with partner company QA Representatives, reporting on key performance metrics
- Advises management on changes to corporate and government requirements. Provides input into emerging internal and external requirements on behalf of CLS Canada
- Represents the company during Health Canada inspections
- Responsible for ensuring that associates follow all company guidelines related to Quality and Regulatory Compliance
- Collaborates with JNJ Pharma, Medical Devices and Consumer on driving common Quality Systems for CLS in Canada
- Knowledge of statistics and the ability to assimilate and analyse information
- Attention to detail and the confidence to challenge others when standards are not met
- Manage stakeholder relationships both internally and externally
List of Typical Skills For a Quality & Compliance Manager Resume
1
Skills For Quality Compliance Manager Resume
- Establish and manage auditor qualification and training to build audit skills of internal SMEs and co-auditors
- Knowledge: Demonstrate experience of service and governance ownership, improvement and process maturity
- Understanding of technical and aviation connectivity principles and their relationship to the service experience
- Experience in leading and managing regulatory agency inspections
- Experience of developing and introducing complex change into an operational environment
- Management: Significant experience of forming and managing a multi-disciplinary virtual team
- Proven ability in managing both individuals and influencing stakeholders
- Good understanding of cGMPs, GDP and FDA regulatory requirements
- Sense of partnership with systems users, ability to advise and give proactive support, with good understanding of internal customer needs
2
Skills For Quality & Compliance Manager UK & Ireland Resume
- Expertise or experience of interacting with competent authorities / local health authorities is an advantage
- Experience on a manufacturing site or with external partners (contractors)
- Experience working in a FMCG company, preferably in highly regulated environment such as Pharmaceutical, Healthcare or Personal Care
- Experience managing continuous improvement practices
- Strong understanding of Change Control Processes
- Previous relevant experience within a Pharmaceutical company (especially at an affiliate)
- Focus attention to details – strong sense of commitment
- Coordinate and prioritize the activities of the team
- Coordinate and/or perform QC checks and remediation actions specified in Annual Quality Plan. Monitor progress and effectiveness of remediation actions
3
Skills For Quality / Compliance Manager Resume
- Experience in implementation and ownership of ITIL Service Operation function
- Experience in above mentioned activities
- Experience in Regulatory Affairs and/or Quality department
- Experience working in the Healthcare, Pharmaceutical, or Medical Device related industry
- Experience working in a quality compliance function in Healthcare, Pharmaceutical, or Medical Device related industry
- Have experience of writing reports for various Management Levels
4
Skills For CLS Quality & Compliance Manager Resume
- FDA or Notified Body experience required
- Training of Quality and Manufacturing personnel in the principles and application of cGMP pertaining to work that supports cGMP auditing among others
- Hiring, coaching and mentoring professional Quality staff
- Engineering or post graduate in Engineering or Business Administration
- Working knowledge of computer applications including Word, Excel and Auto Cad
- Understanding of FDA regulations including 210 CFR part 210 and 211
- Authoring of SOPs and supporting process development for key procedures
- Understanding of Service Operations functional domain and service capabilities, and stakeholder management across operational teams
- Challenging: Do not accept the status quo but seek continued process improvements
5
Skills For Clinical Quality & Compliance Manager Resume
- Reporting of results to management and J&J Corporate (as required)
- Conducting quality and compliance reviews of new and updated procedures
- Resolving discrepancies in a timely fashion with appropriate partner
- Lead and develop operational QC inspections including planning, execution, analysis and reporting to suppliers, warehouses and in stores
- Manage the site’s Change Control Program for regulatory impacted documents by initiating, tracking and completing change controls
- Manage the site’s Technical/Quality Agreement Program by preparing, reviewing and verifying agreements in line with the Mylan global standard
6
Skills For Senior Quality Compliance Manager Resume
- Leadership in developing, implementing and maturing Quality Systems
- Provides Quality input and support to the CLS Canada training process including 3PL training
- Develop, implement, communicate a clear product compliance process, guidelines, working methods, checklists SOP, including IT system support
- Responsible for monitoring Affiliate adoption, training, and implementation of local processes in accordance to the applicable Divisional Standards
- Manages regulatory inspections and external audits via preparation, hosting, audit responds and implementing corrective actions as appropriate
- Lead corporate audit scheduling and reporting process
- Develop ongoing training activities related to the Supplier quality management process
- Coordinate with GXP operational groups on developing a holistic Quality Auditing strategy
7
Skills For Global Quality Compliance Manager Resume
- Lead in identification, problem solving and process improvement for all areas that comprise the Leggett and Platt Bedding Group
- Implement continuous improvement and process quality monitoring mechanisms, including analysis of the 4M inputs
- Educational background in Engineering, Manufacturing or Business Management is desirable
- Established knowledge of the quality management principles and all applicable GxP areas including -
- Able to multi task whilst maintaining a very high level of accuracy and attention to detail
- A professional qualification in Quality &/or auditing would be advantageous
8
Skills For Principal Clinical Quality & Compliance Manager Resume
- Knowledge of most common office software (Microsoft Office) and electronic systems related to documentation and training management
- Develop Annual Quality Plan with remediation activities addressing compliance issues and risk signals
- Collaborate with local and central business partners in timely CAPA setting and implementation
- Build team from scratch to the highest level of global working standards
- Familiarity with ASTM, BIFMA, CPSC, and other industry related testing standards
- Proficiency with call monitoring software (e.g. Genesys, Oaisys, Telstrat)
- Direct working knowledge of the business environment outside of the Quality organization
9
Skills For Service Growth Markets Service Quality & Compliance Manager Resume
- Expertise in directing quality control for a large scale multi-state or national Employee Assistance Program
- Sound working knowledge of requirements & capture methodologies
- Capable of working tactically ‘hands on’ as well as strategically with Sr. Leadership
- Flexibility: Being mentally flexible, to adjust to new information with ease and able to handle multiple tasks
- Knowledge of manufacturing and quality technologies
- Acts as owner and primary contact for the local Regulatory Authority regarding registration of products distributed by Roche Diagnostics in Egypt
10
Skills For Imex Quality Compliance Manager Resume
- Informs the local organization (i.e. Logistics and Marketing), of registration status of Roche Diagnostics products to ensure legal import and distribution
- Specifies requirements for local labeling of Roche Diagnostics products (where applicable)
- Recalls- Responsible for the coordination and execution of product recalls, ensuring robust oversight and compliance in the product retrieval process
- Manage Local Training activities as necessary
- Responsible for initial compliance assessment and approval of Distribution Centers & Embellishers handling RB Products
- Provide leadership and coaching to the CLS Quality team as well as set goals and objectives
- Oversees the quality activities in the DCs, ensuring GMP and GDP compliance for the distribution operations
List of Typical Responsibilities For a Quality & Compliance Manager Resume
1
Responsibilities For Quality Compliance Manager Resume
- Acts as the Site QCMS/ISO coordinator. Monitors and maintains plant QCMS program by complying with current Kraft Heinz and ISO Standards. Ensures all internal procedures, processes are accurate and performing to expectations. Works with internal auditor(s), and, document coordinators(s) to ensure compliance and system improvements
- Manages Quality systems associated with eQCMS, and, Plant Quality team sites to provide access to corporate links easily. Supports the updating of Quality refresher training (e.g. GMP’s, allergens, hold/release, Special Situations) as needed
- Conduit between Plant and Corporate Manufacturing Quality, Sector Quality, Regulatory. Ensures Quality policies are understood and communicated to Site employees
- Provides Quality/Sanitation support for major project commercialization’s from a regulatory, and, Kraft Heinz procedural perspective. Periodically audits to ensure appropriate steps, forms, and approvals are completed
- Proven Leadership ability and skills
- Good numerical skills, data analysis/statistical methods
- Strong interpersonal communication skills, able to collaborate successfully and efficiently with internal groups and external Suppliers
2
Responsibilities For Quality & Compliance Manager UK & Ireland Resume
- Extensive experience in Quality, preferably with experience in Quality Assurance and/or Compliance roles at Regional or Global levels
- Good understanding of RB pharmaceutical manufacturing and QC testing operations
- Quality or related experience
- Utilize and maintain strong customer relationships with non-Clinical Development functions whose activities overlap, influence or affect compliance
- Compliance Management Experience or Equivalent
3
Responsibilities For Quality / Compliance Manager Resume
- Demonstrated ability to successfully coordinate with other functions to ensure project success
- Equipment & Process Qualification & Validation within a cGMP environment
- Experience in dealing with stakeholders at all levels and with external parties
- Operational experience in various Quality Assurance roles (Quality Manager or Quality Control Manager)
- Experience in the medical device or pharmaceutical industry
4
Responsibilities For CLS Quality & Compliance Manager Resume
- Experience across the elements of a quality organization – quality systems, regulatory, quality operations and regulatory compliance
- Experience with the distribution practices and requirements of regulated products (drugs / devices)
- Three years of clinical, quality or regulatory experience required
- Military experience and/or deep knowledge of military culture
- To author, review and approve quality technical agreements, validation and technology transfer documents
- To provide technical expertise for solid and liquid dosage forms (soft gel, hard gels, tablets, syrups)
- Good knowledge of Change Management Control Systems such as Trackwise
- Proven track record of Organization and Talent Development and ability to lead in a matrixed environment
5
Responsibilities For Clinical Quality & Compliance Manager Resume
- Medical Device regulations knowledge and experience required
- Professional work experience in a Clinical Development/Research environment
- Addressing compliance review of reports and recommending appropriate course of action
- Providing information to, or supporting activities from the CBRE Quality function
- Broad understanding of manufacturing operations business and quality management systems
- Drive immediate action on quality outputs showing non-conformance
6
Responsibilities For Senior Quality Compliance Manager Resume
- Warn senior stakeholders of impending changes in the legislative and/or global policies and procedures which could impact resources
- Thorough knowledge of the legal requirements, rules and guidance covering the manufacture of pharmaceutical products in Europe
- Undertake regional process analysis, developing common compliance methods and processes to drive standardization across the global operation
- Thorough knowledge of International Standard ISO 9001 Quality Management Systems and ISO 14001 Environmental Management Systems (ISO/TS 16949 as applicable for automotive sector) is mandatory. Demonstrated experience in previously managing and implementing ISO quality systems
- Experience with quality improvement tools and techniques (i.e., Lean, Six Sigma, Statistical Process Control, and Failure Mode & Effects Analysis)
- ISO Certified Level 3 Auditor
- Monitors supply chain quality, as applicable, and ensures that product specifications are maintained throughout the supply chain
- Serves as local contact for GQC and as the Affiliate conduit for sharing of information related to Quality Management; e.g. ensures that any communication related to new/updated Divisional Standards are forwarded to the local staff responsible for those processes
- Ensures appropriate Quality Management related processes are in place, communicated, and that relevant employees are adequately trained
7
Responsibilities For Global Quality Compliance Manager Resume
- Provides timely feedback to the Global Regulatory Submissions Affiliate Coordinator and the BA/GPS Regulatory functions on changes to local regulatory requirements
- Cooperates with Global Regulatory Submissions and local manufacturer associations to influence registration requirements
- Provides information and interpretation regarding regulatory requirements to the Global Regulatory Submissions Affiliate Coordinator and BA Regulatory functions needed to develop Regulatory Strategy, Clearance Plans and Regulatory opinions
- Provides Regulatory training to employees as required to meet compliance with local laws and regulations
- Ensures compliance with Roche, local promotional requirements and Regulatory Divisional Standards
- Work with CMO QA to establish, harmonize, and update CMO CH Quality Agreements between GSK and our contractors
- Directing, planning, and layout of the details of standards, methods and procedures to be used by the inspection and production personnel to assure adherence to all applicable FAR’s and customer and manufacturer’s specifications
- Ensure inspection and test standards are in place and comply with applicable FAR’s, manufacturer’s specifications, recommendations, and customer requirement
- Ensure that all technical data (i.e.: manufacturers’ service manuals, instructions, service bulletins, etc.) on all articles maintained or altered are secured and kept current with latest revisions by the respective department
8
Responsibilities For Principal Clinical Quality & Compliance Manager Resume
- Handles review of all PAR’s submitted and sign off for MCL
- Establish and manage Annual Quality Plans approved by Country LOC Quality Lead
- Measure & monitor centrally approved KPIs. Ensure they are continuously embedded across the LOC/LOCs organization
- Review, and implement QMS policies. Applicable Processes and Systems for all LOCs would include (but not limited to)
- Corrective and Preventive Actions (CAPA) (including RCA and deviations)- Develop local processes based on global ones to conduct root cause analysis to investigate GxP deviations and develop CAPA’s. Local Demonstrate that LOC effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out
- Manage quality alerts and regulatory intelligence
9
Responsibilities For Service Growth Markets Service Quality & Compliance Manager Resume
- Ensure Annual Product Review (APR) is available and appropriately reviewed
- Ensure the maintenance of the QMS through the appropriate impact assessment and QMS Management review processes
- Maintain a Fit-For-Purpose QMS:Report level of compliance of local QMS versus Global Policies and GDP/local requirements regularly to Regional Quality Director, GM’s, SVP’s, EVP’s and drive closure of gaps to maintain
- Develops Quality Agreements with J&J Partner Companies and 3PLs
- Serves as back-up for CLS Quality and Compliance Director and CLS Quality team members
- Lead the local implementation of JNJ standards
- Drives consistent processes and requirements through the DCs and ensures efficient and compliant SOPs across all Partner companies and 3PLs
10
Responsibilities For Imex Quality Compliance Manager Resume
- Negotiates with regulatory authorities on quality and compliance issues
- Responsible for the preparation of the Quality System Management Review presentation, co-present with CLS Quality and Compliance Director to provide regular updates regarding the compliance status and performance of CLS
- Manages the internal audit program to monitor compliance with corporate and government requirements
- In partnership with the Director of CLS Quality and Compliance set strategic objectives for CLS Quality in the DCs
- Manages Escalation of issues as per JNJ Standards as directed by CLS Q&C Director
- Participates in projects, acquisitions and divestitures and act as the CLS quality SME
- Represents CLS Quality on Commercial launch and New Business Development initiatives
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