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Senior QA Manager, Computer System Validation (CSV QA) - Consultant

Redwood City, CA 94063

Posted: 04/07/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 618839 Is job remote?: Yes Country: United States

Job Description


Senior QA Manager, Computer System Validation (CSV QA) - Consultant 

The Opportunity:

  • Serve as the Computer System Validation (CSV) QA subject matter expert and provide guidance on and interpretation of global GxP guidance and regulations of computerized systems, electronic records, electronic signatures and data integrity requirements (21 CFR Part 11, EU Annex 11).

  • Provide QA oversight for CSV activities for internal & external electronic systems, ensuring that CSV activities are conducted in compliance with global regulatory requirements (FDA, GAMP) and internal SDLC standards.

  • Implement best practices for data governance/integrity and ensure that all systems meet GxP compliance requirements.

  • Responsible for Quality oversight of Data Integrity and Computer System Validation activities.

  • Review and approve CSV deliverables, GxP change management requests, and quality records (e.g., Deviations, and CAPAs) to ensure adherence to Quality requirements.

  • Lead QA audits and/or assessment for supplier qualification or requalification of electronic system service providers.

  • Support process improvement efforts of computerized system policies, procedures and computerized system validation processes.

  • Collaborate across functions and within Quality to identify areas of improvement and implement enhancements.

  • Provide guidance to cross functional team, educate and train as necessary on risk-based approach for deployment of GxP systems.

  • Support Inspection Readiness initiatives, as well as providing support during partner audits and regulatory body inspections.

Required Skills, Experience and Education:

  • Extensive understanding of 21 CFR Part 11, Annex 11, and Data Integrity concepts and controls for computerized systems.

  • In-depth knowledge of GAMP 5, software development, lifecycle methodologies and current industry best practices.

  • Must have broad GxP electronic system experience. Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization preferred.

  • Expertise in 21 CFR Part 11 and EU Annex 11 regulations, data integrity and GAMP5 concepts, applications, and best practices.

Preferred Skills:

  • Hands-on experience in implementing and maintaining data integrity controls.

  • Experience supporting regulatory inspections and audits.

  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence greater outcomes.

  • Possesses strong written and verbal communication skills.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Redwood City, CA

Ready to embark on an exciting career opportunity in the vibrant area around Redwood City, California? Nestled in the heart of Silicon Valley, this thriving region offers a perfect blend of innovation, growth, and charm. From the bustling tech scene to the serene beauty of Redwood City's parks, like Edgewood Park and Pulgas Ridge Preserve, there's something here for everyone. Immerse yourself in the local culture by visiting the Fox Theatre or exploring art galleries like The Art Center and Redwood City Art Kiosk. With a bustling food scene offering everything from trendy cafes to authentic Mexican cuisine, it's no wonder that Redwood City is a top choice for job seekers looking to thrive in a dynamic environment. Browse our job listings today and take the next step towards a fulfilling career in this captivating locale!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.