Senior Corporate Quality - QA IT Validation

This role will be responsible for ensuring GxP computerized systems are validated and controlled in compliance with local (e.g. 21 CFRT parts 11, 58, 210, 211) and international (e.g. Eudralex and ICH Q7) guidelines. This individual will lead the qualification efforts in collaboration with IT using the SDLC of enterprise and server-based applications supporting GxP operations. Additionally, the individual will be responsible for providing Quality oversight of laboratory systems and instrumentation qualification efforts., * Lead and represent QA on cross-functional teams supporting implementation, validation, and maintenance of GxP computerized systems.

• Ensure compliance with company policies, procedures, and regulatory requirements governing computer system validation.
• Provide guidance and oversight on validation strategies, risk-based approaches, and compliance expectations throughout the computerized system lifecycle.
• Collaborate with business owners, system owners, and CSV personnel to support risk-based validation activities and resolve any compliance-related issues.
• Review and approve validation lifecycle documentation, including risk assessments, URS, FRS, CS, test protocols, and validation summary reports.
• Serve as the QA approver for IT-related change controls and associated validation activities.
• Execute and approve periodic reviews for GxP computerized systems.

• Bachelor’s degree in a scientific, engineering, computer science, or related discipline.
• 6+ years of relevant experience in the biopharmaceutical or pharmaceutical industry.
• Direct experience in GxP computerized system validation (CSV/CSA), risk-based validation methodologies and system lifecycle management.
• Solid knowledge of applicable of regulatory requirements and industry best practices, including FDA CSA Guidance for Industry, 21 CFR Part 11, EU Annex 11, ICH guidelines, GAMP 5.
• Ability to work independently and collaboratively within a team with minimal direction.
• Excellent attention to detail and strong organizational and communication skills, both written and verbal.
• Previous QA Validation experience.

Nice to Haves:

• Experience with validating a broad spectrum of enterprise computerized systems, such as Veeva (Quality, RIM, Safety, Clinical), Oracle, TraceLink, LabVantage, Statistica.
• Experience with qualifications of computerized laboratory equipment and infrastructure.