Manager, GCP Quality Assurance (Contractor) - LPExe323

Company: Biotech company based on Alameda, CA

Work Style: On Site or remote: On site in Alameda is preferred.

Type: Contractor (6 months with potential extension)

Summary of type of candidate: This is a strong GCP QA Manager / Clinical Quality Assurance posting. The best candidates will likely come from biotech/pharma QA backgrounds with hands-on audit experience, CRO/vendor oversight, and inspection readiness support.

Job Description:

The client is seeking a contractor as a Manager, GCP Quality Assurance to support global clinical trial quality and compliance activities. This role will apply strong knowledge of Good Clinical Practice regulations, ICH GCP E6(R3), FDA, EMA, and applicable 21 CFR requirements to help ensure clinical trials, investigator sites, vendors, systems, processes, and clinical documents remain inspection-ready and compliant.

The Manager will partner closely with Clinical and cross-functional teams to provide GCP compliance guidance, conduct and oversee audits, identify quality risks, support CAPA review, and contribute to a strong quality culture across the organization.

Key Responsibilities

• Support compliant execution of global clinical trials in partnership with Clinical and cross-functional teams.
• Contribute to the development and execution of the GCP audit plan.
• Conduct and/or oversee audits of clinical investigator sites, internal GCP systems and processes, vendors/CROs, and clinical trial documents.
• Independently manage audit activities, including preparation, conduct, presentation of findings, and audit reporting.
• Identify GCP non-compliance, systemic issues, and process improvement opportunities.
• Communicate significant audit findings professionally and factually to auditees and stakeholders.
• Assist in reviewing and assessing proposed CAPA plans.
• Support GCP regulatory authority inspections and inspection readiness activities.
• Help strengthen and maintain a quality-focused culture within Exelixis.

Qualifications

• Bachelor’s degree, preferably in Life Sciences, STEM, or a related discipline.
• Minimum of 5 years of related experience in biotech, pharmaceutical, or a related industry.
• Strong working knowledge of FDA, EMA, ICH GCP guidelines, ICH E6(R3), and applicable GCP regulations.
• Experience working with CROs, vendors, and clinical trial teams.
• Experience planning, conducting, and reporting GCP audits, including investigator site, process, vendor, and document audits.
• Ability to manage multiple projects in a fast-paced environment.
• Strong written, verbal, communication, and presentation skills.
• Ability to work independently and collaboratively in a cross-functional environment.
• Strong collaboration, negotiation, and problem-solving skills.