Job Summary

The Quality Assurance (QA) Representative will provide quality oversight and compliance support for Clinical Development and Pharmacovigilance (PV) activities related to biologic development programs. This individual will be responsible for ensuring that clinical trial execution, safety reporting, and pharmacovigilance systems meet Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, as well as all applicable global regulatory standards. The QA Representative will partner closely with Clinical, Pharmacovigilance, Regulatory Affairs, and external service providers to ensure high-quality execution of clinical and safety activities that safeguard patient rights, safety, and data integrity.

Job Responsibilities

Clinical Operations Oversight

• Provide QA oversight for the planning, execution, and reporting of clinical trials for biologic programs.
• Ensure compliance with ICH-GCP, FDA 21 CFR Parts 50/54/56/312, EMA regulations, and other international clinical trial requirements.
• Support audit readiness of investigator sites, Clinical Research Organizations (CROs), and internal clinical teams.
• Participate in vendor qualification and ongoing oversight of CROs, ensuring compliance with contractual and regulatory obligations.

Pharmacovigilance Oversight

• Provide QA support for global PV activities, including adverse event (AE) reporting, signal detection, and safety data exchange agreements.
• Monitor compliance with global GVP requirements, including FDA, EMA, MHRA, Health Canada, and other health authorities.
• Support audits and inspections of PV systems and processes, including preparation, participation, and follow-up on corrective/preventive actions (CAPAs).

Quality Systems & Compliance

• Review and manage deviations, CAPAs, and change controls associated with Clinical and PV activities.
• Ensure quality documentation is complete, accurate, and compliant with corporate standards and global regulations.
• Support continuous improvement initiatives across Clinical QA and PV QA functions.
• Provide quality input into regulatory submissions, including INDs, BLAs/MAAs, and safety updates.

Cross-Functional & External Collaboration

• Serve as a QA liaison between Clinical Operations, Pharmacovigilance, Regulatory Affairs, and external partners (CROs, Safety Vendors).
• Support training and awareness of GCP, GVP, and corporate quality policies across internal teams and contractors.
• Facilitate effective communication between internal stakeholders and global regulatory authorities during audits and inspections.

Qualifications

• Bachelor’s or advanced degree in Life Sciences, Biotechnology, Pharmacy, or related field.
• Minimum of 10 years of experience in Quality Assurance within Clinical Operations and/or Pharmacovigilance, preferably in biologics or biotechnology.
• Strong knowledge of global regulatory requirements: ICH-GCP, EU GCP Directive/Regulation, FDA GCP regulations, and international GVP standards.
• Experience with CRO and PV vendor oversight, including audits and inspections.
• Familiarity with electronic systems for clinical and safety data (e.g., EDC, CTMS, Argus, ARISg, Veeva Vault).
• Demonstrated success in managing quality issues, audits, and regulatory inspections.
• Excellent communication, organizational, and interpersonal skills with the ability to influence and collaborate across functions and geographies.

Compensation

• Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas. 

  Pay range: $165,000 - $175,000 per annum

Special Advisory 

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