Director, Quality (Clinical)
$195,000–$230,000 year
On-siteSan Francisco, California, United States
Job Summary
Lead clinical quality strategy aligned with global regulatory requirements and risk-based principles to support late-stage development and Phase 3 execution. Establish fit-for-purpose quality practices ensuring clinical data integrity and inspection readiness across clinical and nonclinical activities. Execute quality oversight plans including study-level, CRO, vendor, site, and system evaluations while managing deviation investigations, root cause analysis, and CAPA management. Provide quality guidance, assess clinical quality and data integrity risks, and partner with cross-functional teams to embed quality expectations into study planning and execution. Maintain inspection readiness and support targeted audits and pre-inspection assessments as needed.
Required Qualifications
- Bachelor's degree in life sciences, health sciences or related discipline
- At least 10 years of GxP quality experience
- Deep experience in GCP oversight
- Global clinical development experience
- Strong knowledge of global GxP regulations (GCP, GLP, GMP, GVP, GDP)
- Regulatory expectations for late-stage clinical programs
- Experience developing audit strategies
- Overseeing vendors and CROs
- Supporting inspection readiness
- Supporting regulatory interactions
- Developing clinical quality oversight plans
- Study evaluation experience
- CRO oversight experience
- Site oversight experience
- System oversight experience
- Focused data evaluation experience
- Ability to independently assess complex clinical quality issues
- Developing well-supported recommendations
- Scientifically sound judgment
- Operationally sound judgment
- Regulatorily sound judgment
- Ability to evaluate clinical data integrity
- Endpoint reliability evaluation
- Documentation quality evaluation
- Monitoring effectiveness evaluation
- Vendor data flows evaluation
- Inspection readiness of clinical trial data evaluation
- Experience with computerized system validation for clinical and nonclinical systems
- Regulated environment experience
- Ability to assess risk
- Solve complex problems
- Implement practical, scalable quality solutions
- Strong written and verbal communication skills
- Collaborative, team-oriented approach
- Strong quality judgment
- Ability to identify material clinical quality risks
- Escalate appropriately
- Drive issues to resolution across functions and external partners
- Ability to thrive in a fast-paced, dynamic environment
- Comfortable with change and ambiguity
- Flexible, proactive, and hands-on mindset
- Roll-up-your-sleeves, can-do attitude
- Demonstrated understanding of hospital and clinical care environments
- Direct healthcare experience (e.g., nursing, allied health, or medical background)
- Experience supporting clinical trials in academic medical centers, hospitals, CROs, or the biopharmaceutical industry
Desired Qualifications
- Advanced degree
- Experience in rare disease
- Cardiovascular clinical development
- Specialty disease clinical development
- Experience supporting preparation for major regulatory submissions (NDA/BLA/MAA)
- Experience with nonclinical quality oversight
- GLP compliance experience
- Nonclinical vendor oversight experience
- Working knowledge of GDPR
- Clinical trial data privacy requirements knowledge
- Audit and/or quality certification (e.g., CQA, RQAP-GCP, ISO Lead Auditor)
- Experience with ICH E6(R3)
- Risk-based quality management experience
- Centralized monitoring experience
- Quality tolerance limits experience
- Critical-to-quality factors experience
- Evaluating CRO and vendor data integrity
- Data transfers experience
- Data transformations experience
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