american statistical association asaSan Diego, CA
Director, Clinical Quality Assurance
Director, Clinical Quality Assurance
Director, Clinical Quality Assurance
american statistical association asaSan Diego, CA
yesterday
Research and Development in BiotechnologyPharmaceutical Preparation ManufacturingBiological Product Manufacturing
Apply for this role (opens in a new tab)Clinical QA LeaderIn this role you will provide strategic and operational leadership for the Clinical QA function to ensure GCP compliance across all clinical programs. You will build and maintain a risk-based quality framework supporting development, regulatory submissions, and inspection readiness. You will partner with cross-functional teams to proactively identify and mitigate quality risks and foster a culture of continuous improvement. A key hook is leading robust audit programs and inspection readiness in a fast-paced biotech environment, shaping quality across the lifecycle.
Responsibilities:
- Define and execute the Clinical QA strategy aligned with development goals
- Develop and continuously improve phase-appropriate, risk-based quality systems, SOPs, and policies
- Identify, assess, and mitigate quality and compliance risks using proactive, risk-based approaches
- Provide ongoing GCP quality oversight for adherence to global requirements across programs
- Collaborate with Clinical Operations, Regulatory Affairs, Data Management, Biometrics, CMC, and study teams to manage compliance risks
- Oversee QA oversight of CROs, laboratories, and other vendors with qualification and monitoring
- Review and contribute to essential clinical/regulatory documents (INDs, protocols, NDAs, etc.)Lead the planning and execution of a comprehensive, risk-based GCP audit program
- Manage audit findings and drive CAPA implementation
- Lead investigations of deviations/noncompliance with root-cause analysis and documentation
- Lead inspection readiness activities for late-phase programs and global regulatory inspections
- Ensure systems are inspection-ready and aligned with evolving regulatory expectations
- Serve as Clinical QA lead for regulatory inspections, including preparation and response
- Support NDA/BLA/MAA submission activities from a quality perspective
- Embed quality principles across the clinical development lifecycle
- Develop and deliver annual GCP training and communicate regulatory changes to stakeholders
- Collaborate with the broader Quality team to align GxP objectives and foster a culture of readiness
Key requirements:
- 10+ years of progression in GCP Quality Assurance in biotech/pharma
- Direct experience supporting Phase 2/3 trials and NDA/MAA submissions with inspection readiness
- Expert knowledge of global GCP regulations and guidance (21 CFR 11, 50, 54, 56, 312; EU-CTR; ICH E6(R2/R3), ICH E8; GDPR; GCLP)
- Extensive experience leading GCP audits (internal, sites, CROs, vendors) and regulatory inspections
- Ability to operate strategically and hands-on in a small, fast-paced biotech environment
- Excellent communication, collaboration, and influencing across cross-functional teamsstrategic mindsethigh integrity and commitment to qualityleadership with stakeholder influencerisk-based quality systemsGCP knowledge and clinical development processesaudit program management (CROs, sites, vendors)
Also on the board Same function, level within a rung
Level
Manager
Location
San Diego, CA
Occupation
Quality Control Systems Managers
Industry
Research and Development in Biotechnology
Posted
yesterday