Director, Enterprise Risk Management
HybridPhiladelphia, Pennsylvania, United States
Job Summary
Design, implement, and lead the enterprise risk management framework, including governance structure, risk taxonomy, and escalation pathways. Facilitate periodic risk assessments with executive leadership and functional owners to maintain the corporate risk register and heat maps. Partner with Clinical, Regulatory, Quality, and Commercial leaders to identify emerging risks, define mitigation plans, and track remediation to closure. Integrate risk management with quality risk management (ICH Q9), business continuity, third-party/vendor risk, and inspection readiness. Lead the application of quality risk principles across the product lifecycle and establish a risk-based oversight framework for the external manufacturing network of three CDMOs. Serve as a trusted advisor to the Chief Compliance Officer and contribute to inspection readiness and BLA submission activities. Build scalable tools, templates, and processes appropriate for a clinical-stage company transitioning to commercial operations.
Required Qualifications
- Bachelor's degree in life sciences, business, finance, or related field
- 10+ years of progressive experience in the biopharmaceutical industry
- Significant experience in enterprise risk management
- Significant experience in quality risk management
- Demonstrated experience designing or leading an ERM program
- Hands-on experience applying quality risk management (ICH Q9) in a GxP environment
- Experience applying quality risk management principles (ICH Q9(R1)) across the product lifecycle
- Experience managing or overseeing risk across multiple CDMOs or contract manufacturing partners
- Experience supporting or operating within a pre-launch or newly commercial organization
- Strong facilitation skills
- Strong analytical skills
- Strong communication skills
- Comfort with ambiguity
- Hands-on, roll-up-your-sleeves orientation appropriate for a clinical-stage company
Desired Qualifications
- Advanced degree (MBA, MS)
- Relevant certification (e.g., CRMP, ARM, CQA)
- Experience in cell and gene therapy
- Experience in rare disease
- Experience with other specialty/complex products
- Experience with cell therapy or viral vector external manufacturing networks
- Experience with associated supply chain risk
- Experience presenting to boards or board committees
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