Kelly Services Software Quality Assurance Lead in Cambridge, Massachusetts
Software Quality Assurance Lead
Kelly Services is seeking a Software Quality Assurance Lead for a leading company located in Cambridge, MA .
If this position may be interested to you, please email me back at email@example.com (with your most up to date resume in word format) and advise the best time and number at which you can be reached.
The successful candidate will have the opportunity to work with our client, a multinational pharmaceutical and biopharmaceutical company.
Duration: 6 months (possibility of extension)
Location: Cambridge, MA (Position will start from working from home and eventually transition back to office in Cambridge)
Candidate must be eligible for direct W2 contract without employment sponsorship.
Under the direction of the Head, Data Systems, R&D Quality Assurance and Compliance, this role is responsible for providing support in software quality assurance overseeing of systems validation activities related to systems utilized by the Research & Development team. You will provide compliance leadership and direction to business and project teams in Software Development Life Cycle / System Validation (CSV)/Lab Systems/Lab Equipment/Infrastructure Qualification standards and practices.
This is accomplished by:
Providing professional expertise, guidance and strong leadership in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/GAMP 5) as applicable to the Global R&D GxP requirements (GLP, GCP, GPvP, GDP) to proactively identify compliance issues/risks in all functions within the organization and its external partners.
Participating in the delivery of system solutions by overseeing/reviewing SDLC/CSV/Qualification activities.
Guiding development of validation/qualification/migration/verification strategies for software (including lab), data, mobility, hardware, infrastructure/components and/or business processes prior to release into a live environment per company procedure(s).
Overseeing execution of validation/qualification/verification/migration strategies per company procedure(s).
Providing validation/verification/qualification guidance to stake holders as necessary.
Managing relationships with key customers and stake holders to ensure oversight that the total validated/verified/qualified solution delivered meets/exceeds expectations.
Ensuring SDLC/CSV/Qualification activities are conducted in a compliant and timely manner.
Subject Matter Expert on SDLC/Qualification procedures and regulations and able to provide guidance to IT and/or Business.
Participate on cross functional teams to oversee validation/verification, implementation, and maintain regulated (Example: GxP, JSOX etc.) systems across the Organization.
Oversee the validation/verification/qualification strategy development by working with the validation team.
Work with project team’s offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
Ensure the project testing scope is met per specified agreement and/or scope change.
Understands the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.
Thoroughly understands the difference between Positive versus Negative Testing.
Insure all SDLC deliverables are completed and stored appropriately.
Leads resolution efforts when issues are identified and escalate appropriately.
Actively share emerging industry standards/trends with customers and peers within area of responsibility.
Guide the response and remediation of corrective actions and internal audits.
Cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks.
Proactively identify and assist in prioritizing opportunities to streamline validation and or qualification efforts but still stay compliant.
Bachelor’s Degree in Life Science or Computer Science
Minimum 10 years of software quality assurance experience with lead experience.
Broad knowledge of software development life cycle.
Must have pharmaceutical industry experience and familiar with GxP.
Demonstrated experience leading cross functional teams advising on compliance related matters and influencing Senior Leaders.
Possess the following qualifications is added advantage:
American Society for Quality (ASQ)
Certified Software Quality Engineer (CSQE)
Quality Assurance Institute (QAI)
Ability to fly to travel regionally and globally for meeting if required.
Professional Technical Recruiter
Kelly Services, Inc
Why Kelly ® ?
By partnering with Kelly® IT, you’ll have direct connections to top companies around the globe—giving you the chance to put your tech skills to work on some of today’s most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. We’re here to help you gain experience, keep learning, and move your career forward.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
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