What are the responsibilities and job description for the Sr. Manager, Quality Risk Management position at Astrix?
Pay Rate Low: 90.00 | Pay Rate High: 116.00
Sr Manager, Quality Risk Management (Pharma) – Contractor
Location: South San Francisco, CA or Princeton, NJ
Schedule: Hybrid role (1-2 days in office)
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).
This role emphasizes mindset and influence as much as technical depth. An experienced QRM subject matter expert will provide mentoring, making this an excellent opportunity for a strong pharma quality professional who can coach, guide, and bring teams along as the organization strengthens its risk-based ways of working.
Key Responsibilities
Sr Manager, Quality Risk Management (Pharma) – Contractor
Location: South San Francisco, CA or Princeton, NJ
Schedule: Hybrid role (1-2 days in office)
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).
This role emphasizes mindset and influence as much as technical depth. An experienced QRM subject matter expert will provide mentoring, making this an excellent opportunity for a strong pharma quality professional who can coach, guide, and bring teams along as the organization strengthens its risk-based ways of working.
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
- 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
- Practical experience supporting Quality Risk Management and/or RBQM activities aligned with ICH Q9 and/or ICH E6 (R3)
- 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!***