Director Quality Assurance - Permanent - San Francisco, CA
Shape and lead phase‑appropriate GxP quality oversight for clinical‑stage development programs.
Proclinical is seeking a Director or Senior Director of Quality Assurance (GxP) to provide strategic, phase‑appropriate quality leadership for clinical‑stage development programs. This role is responsible for establishing and maintaining robust quality oversight across GMP, GCP, and GLP activities within a predominantly outsourced operating model.
This role has a strong focus on GxP Quality Assurance oversight, including quality systems, vendor oversight, and inspection management, with close collaboration across clinical, technical, regulatory, and operations teams.
Primary Responsibilities:
The successful candidate will help shape and implement risk‑based, fit‑for‑purpose quality processes aligned with the organisation's development stage and evolving business priorities. The position will act as an independent quality partner to internal stakeholders and external service providers, supporting regulatory compliance, inspection readiness, and effective quality systems governance.
Skills & Requirements:
- Bachelor's degree or higher in a scientific discipline.
- Strong working knowledge of GxP requirements (GMP, GCP, GLP) in a clinical-stage setting.
- Experience managing quality activities in a highly outsourced development model, including oversight of CROs and CMOs.
- Proven expertise in leading GxP audits, inspection readiness, and regulatory interactions.
- Demonstrated application of risk-based quality management principles.
- Strong stakeholder management and cross-functional influence.
- Ability to operate effectively in a lean, fast-paced environment.
- Excellent communication skills, with the ability to convey complex quality topics to non-experts.
Preferred:
- Experience supporting biologics or gene therapy programs.
- Familiarity with early to mid-stage clinical development (Phase I-II).
- Prior experience scaling or optimizing quality systems in resource-constrained environments.
- Hands-on lab experience with Quality Control release and stability testing is a plus.
The Director Quality Assurance's responsibilities will be:
- Provide independent GxP QA oversight across GMP, GCP, and GLP activities for clinical development programs.
- Oversee quality activities performed by external partners, including CROs, CMOs, CDMOs, and contract laboratories.
- Establish and maintain Quality Agreements to define roles, responsibilities, and compliance expectations.
- Lead and manage the GxP audit program, including vendor qualification and ongoing oversight.
- Maintain and improve phase-appropriate Quality Management Systems (QMS).
- Oversee eQMS processes such as document control, change control, deviations, CAPAs, complaints, and batch disposition.
- Ensure data integrity and compliance through QA oversight of internal and external activities.
- Approve or reject clinical batches in accordance with regulatory requirements.
- Lead inspection readiness strategies and execution for FDA and other global regulatory inspections.
- Serve as the primary Quality representative during regulatory inspections and audits.
- Develop responses to regulatory observations, including root cause analysis and CAPA implementation.
- Implement risk-based QA approaches to prioritize oversight across development activities.
- Conduct targeted quality risk assessments across programs and functions.
- Communicate quality risks, trends, and mitigation strategies to senior leadership.
Compensation:
- $200 000.00 - $250 000.00 Per Annum
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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