Sr Manager, Quality Risk Management - PART TIME We're hiring a Senior Manager, Quality Risk Management to join a rapidly-growing, well-funded biotech building innovative life sciences solutions and scaling its quality systems. This is a hands-on role working in Veeva to build compliant processes from the ground up. Previous GCP experience is required!
Location: Must be local to South San Francisco, CA or Princeton, NJ
Schedule: Part - Time (20-30 hours)
Pay: $90-$120/hr
Role Overview We are seeking a Senior Manager, Quality Risk Management (QRM) contractor to support the implementation and maturation of risk-based quality management across GxP activities. This role partners closely with Quality, Clinical, CMC, and functional teams to embed practical, inspection-ready QRM and RBQM practices aligned with ICH Q9 (R1) and ICH E6 (R3).
Key Responsibilities - Support implementation of a pharma-focused QRM framework aligned with ICH Q9 (R1) and integrated into the QMS
- Facilitate and support risk assessments across:
- Clinical development (RBQM per ICH E6 (R3))
- Tech Ops (CMC)
- Quality
- Vendors and outsourced activities
- Help identify critical-to-quality (CtQ) factors, define risk controls, and ensure traceability to quality processes
- Coach and guide cross-functional teams in applying risk-based thinking to decision-making
- Support inspection and audit readiness by helping teams clearly articulate risk rationales and controls
- Contribute to risk metrics, trending, and continuous improvement activities
Required Qualifications - Bachelor's degree in life sciences, pharmacy, engineering, or related field
- 7+ years of experience in Pharmaceutical Quality, Compliance, Clinical Operations, or related GxP roles
- Previous coaching or leadership experience within GCP
- Practical experience supporting Quality Risk Management and/or RBQM activities aligned with ICH Q9 and/or ICH E6 (R3)
Nice to Have - Experience spanning clinical development through manufacturing
- Familiarity with ICH Q10, ISO 31000, or ISO 14971
- Prior inspection or audit support experience (FDA, EMA)
- Consulting or contractor experience in pharma
***This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!***
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