Sr. Manager, Quality Risk Management

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