We are seeking an experience Quality Risk Management proffesional to join a growing biotech organization developing therapeutics to cure and prevent cardiovascular disease
Pay Rate Low: 100 | Pay Rate High: 120
Length: 6-9 month project (strong chance of converting permanent)
Hybrid 1-2 days/wk in person - 30hrs/wk
Pay: $100-120/hr
Role Summary - We are seeking an experienced Senior Manager, Quality Risk Management (QRM) to support the advancement and integration of risk-based quality management across GxP activities. This role will collaborate closely with Quality, Clinical, CMC, and cross-functional teams to implement practical, inspection-ready QRM and RBQM practices aligned with ICH Q9 (R1) and ICH E6 (R3).
- The ideal candidate views Quality Risk Management as a strategic enabler that drives sound decision-making and operational excellence.
Key Responsibilities - Support the implementation and continuous enhancement of a pharmaceutical-focused QRM framework aligned with ICH Q9 (R1) and fully integrated into the Quality Management System (QMS)
- Facilitate and support cross-functional risk assessments across:
- Clinical Development (RBQM aligned with ICH E6 (R3))
- Technical Operations (CMC)
- Quality functions
- Vendors and outsourced activities
- Partner with teams to identify critical-to-quality (CtQ) factors, establish appropriate risk controls, and ensure traceability within quality processes
- Guide and coach stakeholders in applying risk-based thinking to business decisions and operational activities
- Strengthen inspection and audit readiness by ensuring risk rationales and controls are clearly defined, documented, and defensible
- Contribute to risk metrics, data trending, and continuous improvement initiative
Required Qualifications - Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related discipline
- 7+ years of experience in pharmaceutical Quality, Compliance, Clinical Operations, or other GxP-regulated roles
- Hands-on experience supporting Quality Risk Management and/or Risk-Based Quality Management (RBQM) aligned with ICH Q9 and/or ICH E6 (R3)
- Strong facilitation and communication skills with the ability to tailor messaging to diverse audiences
- Proven ability to influence, coach, and guide teams through change
- Experience across the product lifecycle, from clinical development through manufacturing
- Working knowledge of ICH Q10, ISO 31000, and/or ISO 14971
- Prior experience supporting regulatory inspections or audits (FDA, EMA
Preferred Attributes - Growth mindset with a continuous learning orientation
- Comfortable operating in evolving environments with developing processes
- Collaborative partner who drives alignment and engagement rather than imposing solutions
- Strong belief that QRM is a value-adding capability, not a compliance checkbox