Senior Manager, QA Resume Sample
Reagan Simonis
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Work Experience
Senior Manager, QA
01/2018
-
PRESENT
Chicago, IL
- Oversee QA of multiple, complex, organization-wide systems
- Work with client departments in testing of application programs having impact on improving the business by advising application owners on the technology possibilities and requirements
- Determining appropriate testing methodology to suit technology and business criteria
- Meeting the computing needs of an assigned business unit for specific applications, including assessment and selection of testing technology , as business needs change
- Responding to changing business priorities and system outages (e.g., re-plan, re-prioritize, re-allocation of resources, etc
- Making recommendations regarding the ongoing viability of a project test plan based on ability to deliver upon agreed functionality within approved budget and schedule for medium to large complex projects
- Making recommendations regarding the viability and appropriateness of Testing solution for specific applications, inaccurate assessments could result in moderate financial loss in some portfolios
- Experience in implementing and leveraging metrics
Senior Manager QA for R & D Research & Pre-clinical
07/2014
-
07/2017
Phoenix, AZ
- Adaptable to fast-paced, dynamic work environment and shifting demands
- Extremely strong communication, interpersonal skills and customer focus
- Strong leadership skills with demonstrated ability to effectively work across teams and functions
- Experience in managing people/resources effectively to accomplish established goals
- Proven capacity to effectively manage and escalate risk
- Demonstrated success in a position requiring highly effective communication, facilitation and negotiation skills
- Manage and track KPI’s; develop and implement strategies to ensure that KPI targets are met
- Direct experience to act as contact person for all quality-related issues for BGP Products GmbH’s with Swissmedic, Cantonal Authorities and TPMs
Senior Manager, QA Operations
06/2011
-
04/2014
Philadelphia, PA
- Working closely with peers on release feature deliverables
- Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive data standardization, data analytics, and product quality issue resolution
- Responsible for all metric generations, and a single point of contact for metric and data required by management reviews and performance reviews from Quality Operations and Supplier Quality
- Facilitate cross-site quality focused discussions and problem solving using Lean/Six Sigma principles and root cause analysis; gain results through people strategies
- Engage with on-going Quality System programs, processes and procedures such that they are implemented successfully and function as designed throughout the business group in order to ensure the quality and integrity of manufactured products and corresponding quality data
- Promote quality concepts and principles throughout the organization by facilitating Quality Lead Teams, and by providing feedback for improvement and administration of existing Quality Management System and manufactured products
- Provides leadership and facilitates problem resolution, resource utilization, career counselling, coaching and mentoring of team members
- Experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry. Experience in a related field (drug substance manufacturing) an asset
- BSc/MSc or equivalent education in Science, or related field
Education
Union Institute and University
2006 - 2010
Bachelor's Degree in Science
Professional Skills
- Strong technical expertise - 10+ years of diverse skills and experience in Information Technology
- Strong project management and team management skills e.g. planning, budgetary control and people management, including on and off-shore resources
- Excellent, succinct communication and organizational skills as well as attention to detail
- Computer skills, communication capability, interpersonal skill sets, ability to multi-task in fast paced environment, etc}
- Proficient communications skills when interacting with both internal and external parties
- Superior communication skills at an executive level
- Understanding of computer system validation
How to write Senior Manager, QA Resume
Senior Manager, QA role is responsible for leadership, software, retail, training, integration, database, purchasing, shipping, architecture, reporting.
To write great resume for senior manager, qa job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Manager, QA Resume
The section contact information is important in your senior manager, qa 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 Senior Manager, QA Resume
The section work experience is an essential part of your senior manager, qa 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 senior manager, qa responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular senior manager, qa position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Manager, QA resume experience can include:
- Excellent investigational and QA problem solving skills. Ability to focus attention to details
- Strong PC experience and Microsoft programs experience
- Work independently, yet effectively in a team environment
- Experience in software testing in a structured QA environment
- Experience with one or more of the following in an IT related function: Order management systems, Warehouse management systems, eCommerce systems
- Experience leading teams directly or indirectly
Education on a Senior Manager, QA Resume
Make sure to make education a priority on your senior manager, qa resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior manager, qa 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 Senior Manager, QA Resume
When listing skills on your senior manager, qa 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 senior manager, qa skills:
- Effectively allocate QA resources to optimize project portfolio delivery through maximum use of automation testing tools and repeatable testing harnesses
- Demonstrated progression and growth as a Data Analyst through past career experiences
- Experience coaching/mentoring teams and developing career plans, performance evaluations, and identifying advancement opportunities
- Responsible for coaching, training, motivating and evaluating his/her direct reports through effective performance KPI’s
- Previous experience managing bug defect solutions and creating test plans
- Previous experience planning for and scheduling test coverage
List of Typical Experience For a Senior Manager, QA Resume
1
Experience For Senior Manager QA for R & D Research & Pre-clinical Resume
- Proven excellent and consistently used leadership soft skills
- Excellent investigational and QA problem solving skills – e.g
- Understanding of validation process and facility utilities and systems
- Applies Good Manufacturing Principles and leadership in all areas of responsibility
- Oversees the compliance of the validation , facility, and engineering processes
- Good Knowledge of CMC Regulatory affairs
- Perform batch documentation review, release of Finished Product and management of changes, complaints, deviations, validations and product annual reviews
2
Experience For Senior Manager QA Belgium Engineering Resume
- Demonstrates and promotes company vision
- Experience with Quality Systems (Change Control, deviations, complaint management, among others), people management
- Experience in vendors Quality oversight
- Understanding of API manufacturing processes and QC testing
- Take a lead role in hosting Board of Health Inspections for the packaging and warehousing process
- Responsible for supervising, training, and motivating approximately 6 direct reports
- Thorough understanding of cGMPs, ICH, EU and FDA regulatory requirements
3
Experience For Senior Manager, QA Operations Resume
- Function productively in a fast paced and rapidly changing environment
- High credibility and reliability. Is an ambassador for quality based thinking
- In international pharmaceutical and/or biotech industry with responsibility for Quality leadership in an operational setting
- Sound awareness and understanding current quality and regulatory requirements
- Provides supervision and training of direct reports in support of their activities
- Make independent and unpopular decisions
- Define and implement a test data strategy for the various Lines of Business's to support the test data needs
- Manage, mentor and coach staff on test data principles and practices
4
Experience For Senior Manager, QA, External Manufacturing Resume
- Develop and publish KPIs to communicate delivery practices for test data
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; Establishes and supports best practices for problem solving, root cause analysis, and solution selection tools
- Directs the activities of the Plant Quality and Sanitation Departments in the effective/efficient execution of their functional responsibilities
- Collaborate with product owner to identify product and technical requirements and deliver appropriate test design/framework
- Identify the test dependencies, test data requirements and design detailed test cases
- Coordinate the lab/environment configuration that meets the test objectives
- Work in an Agile environment and meet the specific test execution goal for each sprint/iteration
- Manages all activities, personnel, and technical issues associated with providing technical service and/or solutions to customers by identifying, prioritizing, and confirming resolution of reported problems
- Proactively understands customer's business processes and technical aspects of solutions, the key drivers and measures of success for the business, and the short- and long-term direction of the business and technology
5
Experience For Senior Manager QA / Testing Resume
- Prioritizes effectively: Delivers on critical activities that have an impact across work groups and therapeutic areas
- Set Top Box applications
- Continuous deplyment and integration
- Establish SOP’s for quality standard in collaboration with other departments and based on Global Quality Assurance and or corporate policies
- Make sure that the records, SOP’s and documentation have been completed and endorsed by the staff authorized to do so
- Manage quality trends analysis/quality review/QA reports
- Ensure there is appropriate application of risk management by identifying potential short comings in supplier’s quality systems, considering the risk to patient safety and efficacy, product integrity, regulatory compliance and GSK business
6
Experience For Senior Manager, QA & Integration Resume
- Highly developed communication, organization, and management skills
- Drive a continuous Quality and Compliance improvement mindset within the department to ensure compliance with cGMP’s and GSK Quality Management System
- Ownership and oversight of the disposition/final batch release for the site
- Ownership and oversight of the Risk management program for the site
- Ownership and oversight of post-disposition activities for the site
- Ownership and oversight of the microbial control strategy for the site
- Capable and experienced excellent decision maker and people leader who includes global Pfizer impact awareness on future quality and compliance thinking as a part of decisions
- Capable of metric setting, tracking, trending, evaluating, and drawing conclusions for improvements for the Quality Operations department as the department head
7
Experience For Senior Manager QA, Packaging Resume
- Expertise with investigation of complex technical issues and able to independently handle investigations across cross-functional work areas. Supports above site communication of critical issues and capable to manage communications at the appropriate level
- Manage workload to meet established timelines. Leads and manages work for others. Proactively and independently applies departmental best practices to work assignments
- Has sufficiently broad depth of knowledge of GXPs to be a key contributor and be able to lead continuous improvement to a process or improve business efficiencies
- Works well in the ambiguous space; independently can solve ambiguous personnel, business and technical issues/problems/conflicts
- Independently able to resolve complex issues. Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits
- Interacts constructively and shares experience of quality approaches with other groups developing key partnerships and actively sharing knowledge and expertise within multidisciplinary teams within the OpU in the importance of regulatory compliance
- Influences colleagues from other departments by gathering and disseminating key information and experience. Able to recognize when a multi-disciplinary discussion/issue is beyond their sphere of influence and escalates accordingly
- Team Involvement: Assigned as the Quality member of the project team empowered to speak for the Quality organization to other areas. Provides strategic input to accomplish team objectives. Established interpersonal skills (negotiation, managing conflict) to influence the team
- Experience managing highly complex and/or high impact business systems or products from the Quality Organization perspective
8
Experience For Senior Manager QA Change Control & Document Control Resume
- Responsible for Quality Operational oversight of current licenced activities at Alexion College Park i.e. Storage, Secondary Packaging and Quality Control
- Lead the QA Finished Product team and support on-line support for Operation activities and functions
- Coordinate with peer internal Quality Groups to ensure on-time disposition of Alexion Finished Product
- Provide QA and compliance support to new product introductions, equipment and process qualifications and other projects and sites relating to current licenced manufacturing activities, including new businesses initiatives (e.g. product and country launches)
- Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions
9
Experience For Senior Manager QA Value Stream Resume
- Operate, sustain and improve site quality and operational performance through active participation within Site Operational excellence processes and structures
- Previous direct experience within Quality Control
- Proven competence in process improvement and project execution
- Support audits of CMOs executed according to Alexion external audit program
- Familiarity in the use of enterprise systems for the management of product and associated records and quality documentation
- Represent the company and to negotiate at different levels contacts both internally and externally
10
Experience For Senior Manager QA, Compliance Resume
- Manages the investigation, and Change control processes
- Provides Quality support to assign client accounts
- Implements and monitors key performance indicators (KPI’s) within area of responsibility
- Thorough knowledge of cGMP in the pharma/Biotech industry as well as EU and FDA regulatory requirements, ICH guidelines
- In-depth risk management knowledge
- Thorough knowledge of and competence in core quality processes - including change control, product complaints, deviations/OOS, CAPA management, investigations, APR-PQR
- Quality oversight of the activities and services provided by the assigned CSPs – e.g
List of Typical Skills For a Senior Manager, QA Resume
1
Skills For Senior Manager QA for R & D Research & Pre-clinical Resume
- Previous experience shipping video games for multiple mobile devices
- Previous experience coordinating between internal and external test teams
- Good understanding of Capital Markets Trade Life Cycle and Derivatives Technology
- Appraises outstanding issues impacting the promotion of code to the Production environment and provides direction to minimize associated risks
- Leads preventative programs, process optimization efforts, problem solving and troubleshooting efforts for resolution of incidents
- Collaborates with technology suppliers & vendors in defining and development of technologies to support internal and external testing needs
- Knowledge of formal testing methodologies, test automation techniques and the defect reporting processes for a cross platform environment
- Assures compliance to all applicable regulations by proactively interpreting regulatory and compliance
- Leadership and expertise in team building
2
Skills For Senior Manager QA Belgium Engineering Resume
- Experience in restaurant systems QA testing. Direct management experience with QA teams or 5+ years in test related oversight supporting software development
- Maintains current knowledge of emerging trends and technologies. Serves as a technical resource
- Provides training and/or opportunities for career development of staff
- Attend and support the Management Team and Steering Committee for projects in the assigned portfolio
- Ensure project forecasting of cost
- Approves the timing of releases within an integrated test schedule
- Coordinates through QASS in support of customer and cross LOB testing efforts
- Previous knowledge and expertise using JIRA
3
Skills For Senior Manager, QA Operations Resume
- Develops and executes training programs related to quality, sanitation, and regulatory issues
- Conducts manufacturing facility audits as appropriate to ensure and verify regulatory, customer, and internal compliance
- Develops and maintains Food Safety and Quality documentation (including programs, policies, specifications, HACCP/System Control Plans, and work documents)
- Leads and coordinates activities associated with new and changing items and processes
- Provide quality oversight into the design, specifications development, installation, testing of production equipment and systems
4
Skills For Senior Manager, QA, External Manufacturing Resume
- Software infrastructure development, testing and maintenance
- Ensures staff has performance plans with metrics in place. Reviews are conducted twice a year (mid-year
- Identifies and manages performance/discipline issues
- Provide stakeholder management and support
- Educate stakeholders on project approach
- Vendor / partner relationship management
- Oversees projects managed by Quality Assurance Managers and Quality Assurance Leads
5
Skills For Senior Manager QA / Testing Resume
- Defines and manages the testing strategy for large, complex projects by reviewing and evaluating requirements and design documentation, developing test strategies, approving the preparation of comprehensive test documentation, overseeing daily testing activities and monitoring the ongoing progress of testing
- Participates in the process of establishing, communicating and managing objectives, strategies and plans for the testing environments (SIT and UAT)
- Assesses the test requirements of projects and releases
- Approves test evaluations, review code implementation strategies and authorizes recommendations for promotion of code to the Production environment to ensure the highest quality of service in the delivery of Information Management initiatives
- Author, gain approval, and implement Quality Standard Operating Procedures and Quality Standard Records used in GMP systems and applications
- Develop, implement and maintain Quality systems and activities for Peregrine Quality Assurance, Clinical Products
- Review and approve batch records of products manufactured by third party CMO
- Work with/Assist the Associate Director of QA on a wide range of difficult issues that impact multiple functions, following cGMP regulations and company standards
- Serve as Quality lead on development project(s) as assigned
6
Skills For Senior Manager, QA & Integration Resume
- Perform assigned tasks and work to achieve company goals and department objectives
- Develop and evaluate personnel to ensure the efficient and compliant operation of the operational group
- Directs team to actively and frequently engage with key stakeholders across the LoB’S including Architecture, Development and Delivery Manager to assess test environment issues and initiate, track and prioritize remediation activity
- Collaborates with MSP and LOB to ensures LOB’s have and maintain a dynamic and flexible work force that is required to support the constant changing priorities, project schedules, and technology through cross-training, documentation, and mentoring programs
- Builds and maintains business relations across the Travelport LoB’s to ensure QASS is providing the required services and support in meeting their business objectives and seen as “enablers” and proactive in their engagement
- Coordinates with MSP and QASS to establish and implement KPI metrics (process capability, control charts, measurement quality) for monitoring system effectiveness that enable leads/managers to make sound product quality decisions and distributes required information out to key stakeholders in the various LoBs
- Capable of effectively managing up to 10 direct reports in a dynamic environment
- Working knowledge of ERP Systems, Experience with SAP
7
Skills For Senior Manager QA, Packaging Resume
- Quality-assurance experience in video games, with at least two full cycles on a mobile title
- Experience in leading large scale transformation initiatives, leveraging a variety of delivery models
- Experience leading software development and delivery in commercial software including
- Strong understanding in CRM Salesforce Customization, Mulesoft, PEGA
- Experience facilitating in the integration opportunities for the manual and automated test tools
- Experience working with 3rd party and offshore vendors
- Recruit and develop a team of world class skilled testing resources
- Experience with direct contact with FDA, EMA, Health Canada, KFDA, ROW health authorities/Global Competent Authorities, and ISO Notified Bodies
8
Skills For Senior Manager QA Change Control & Document Control Resume
- Experience with CAPA processes including investigational technique
- Strong analytical aptitude (i.e. statistical techniques, database development)
- QP Eligibile with previous experience in batch disposition
- Experience within the Payments domain
- Consulting--Knowledge of approaches, tools, techniques and roles and responsibilities in providing technical or business guidance to clients within QA
- Working knowledge of Lean Manufacturing/Six Sigma Concepts
- Play and learn new games well
- Relocation to Mumbai India is required
- Software Quality Assurance - Knowledge of activities, tasks, tools and techniques for evaluating new or enhanced systems, software packages and software tools to ensure adherence to functionality and quality requirements
9
Skills For Senior Manager QA Value Stream Resume
- Proven experience in establishing a Plant QA Engineering Operations function for the approval of batch records, work orders, deviations, CAPA’s and Change Controls in an efficient and sound process
- Certifications: Quality Engineering and/or Auditor certification. Lean Manufacturing and Six Sigma training desirable
- Withstand pressure, self-motivated
- Experience: 12-15 years experience in the FDA regulated industry preferably medical devices and tissue technologies with extensive knowledge of cGMPs, and medical device regulations
- Comfortable with decision-making on diversified issues and communicating directly with customers on a routine basis
- Leading testing teams on large and complex projects
10
Skills For Senior Manager QA, Compliance Resume
- Deep knowledge of testing industry trends and tools with specific focus on automation capabilities and frameworks
- Awareness of Canadian Banking and financial institution environment
- Demonstrated knowledge of regulations including FDA 21 CFR 820, 1270 and 1271, AATB requiements, ISO 9001, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards
- Previous assignment experience promoting or requiring global perspective desirable
- Participate in selection of professional services/vendor management
- Familiarity of SQL knowledge and its appropriate use in the test data identification analysis
List of Typical Responsibilities For a Senior Manager, QA Resume
1
Responsibilities For Senior Manager QA for R & D Research & Pre-clinical Resume
- Responsible for colleagues objective setting, conducting one on one meetings with Colleagues, providing guidance/coaching, assisting with colleague development planning, and completing performance reviews
- Determines appropriate training curriculums for colleagues
- Responsible for review, approval and final authorization of cGXP documentation (e.g. data records, reports, protocols, batch records, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values
- Manage a working area and manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines
- Responsible for participating in, leading, or providing guidance for investigations
2
Responsibilities For Senior Manager QA Belgium Engineering Resume
- Familiarity with test automation and its appropriate use in the overall test strategy
- High ethical standards required to uphold compliance
- Expert knowledge of software development methodologies and practices
- Implement quality, operational, and service management processes and ensure speed, agility and improved delivery quality
- Working knowledge of QA Operations disciplines including Purchasing Controls, Identification and Traceability, Production and Process Control, Non-conforming products, Handling Storage and Distribution and Corrective and Preventive Action
- Hospitality systems experience and/or hospitality systems development, testing and project management in the following areas
- Working knowledge data models, database design development, data profiling, and analysis tools (Minitab)
3
Responsibilities For Senior Manager, QA Operations Resume
- BS or MS or equivalent education in Science, or related fields
- Provides 24/7 and tier 1 service for Retail Banking and parts of Wholesale Banking, as well as key enterprise technology capabilities such as Electronic Payment Services to process financial transactions supporting multiple digital channels
- Responsible for training, development and coaching of staff as well as ensuring consistency of processes being implemented
- Ensure that test milestones are met by anticipating issues, managing resources and risks
- Drive best practices and continuous improvement of test processes. Ensure that adherence to technical standards, process and policy is being followed
- Leads the QA efforts for real-time fraud management
- Encourage and develop reports so they advance in their technical expertise and business acumen
4
Responsibilities For Senior Manager, QA, External Manufacturing Resume
- Define responsibilities, assign resources, create, maintain and monitor test schedules and budget for project portfolio
- Manage test processes and deliverables for multiple concurrent projects
- Responsible to understand current test methodologies and effectively facilitate, implementing these methodologies in an IT organization. Ensure that adapting these methodologies and best practices continually meet business needs and are aligned with IT processes
- Works collaboratively to plan portfolio and project deliverables and provide status updates to Project Managers and Senior management on a regular basis
- Relocation assistance eligible, but not a full relocation package
- This job is (Pfizer) (Exempt) (US/PR) Grade: 014
- Define the overall program test strategy and own the overall execution of testing across all workstreams, including but not limited to: Deep End-to-End solution knowledge to align dependency and test approach across all components; delivery and implementation approach to ensure solution is testable and delivers quality results to customers/employees
- In close collaboration with the LOB technology team and the QASS COE QA and the strategic partners, the QA Delivery Owner ensures the testing technology stack available for each test team within the assigned LOB is the most effective and efficient for the architecture and design deployed with that LOB’s products, projects, work packages and M&PS efforts
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