Director, Supplier Quality, Inspection & Audit

The Director, Supplier Quality, Inspection & Audit role will provide strategic leadership and tactical support for supplier quality management, GxP supplier audit programs, inspection readiness, and supplier quality oversight across the portfolio. Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders.

Description of Role

The Director, Supplier Quality, Inspection & Audit role will provide strategic leadership and tactical support for supplier quality management, GxP supplier audit programs, inspection readiness, and supplier quality oversight across the portfolio. This contractor position reports to our Executive Director, GMP Quality Assurance as part of our Product Quality team.

Key Responsibilities

Supplier Quality Leadership

• Develop the strategy and tactically support the supplier quality program
• Manage and confirm robustness of the supplier qualification and monitoring programs
• Provide routine status updates/performance metrics on qualified suppliers
• Manage the installment and routine review of quality agreements Audit Program Management

• Lead GMP, GCP, GLP, CSA and GVP supplier audit programs.
• Develop annual audit plans and risk-based audit strategies.
• Perform audits as required
• Review audit findings and track CAPA to closure
• Develop and monitor implementation of remediation plans, as required.

Inspection Readiness

• Drive global inspection readiness initiatives.
• Collaborate to develop process and tools to facilitate inspection and audit management with suppliers

• Support the management of agency inspections and sponsor audits.

• Manage inspection response and related CAPA activities.

Supplier Oversight

• Partner with Procurement, CMC, Clinical Operations, Pharmacovigilance, Nonclinical and Supply Chain on supplier performance.
• Monitors and routinely report on the data supporting the health of the quality systems for critical suppliers.  

Qualifications

• BS/MS in Life Sciences or related field.
• 12+ years pharmaceutical quality experience.
• Extensive audit and inspection management experience.
• Field auditing experience
• Knowledge of regulatory and guidance requirements for GMP, GCP, GDP, GVP, GLP, and CSA

 

Compensation

The annual base salary range for this position is $150,000.00 to $210,000.00. Individual compensation within this range will be determined based on a variety of factors, including location, qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. The Company  also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Director, Supplier Quality, Inspection & Audit is a remote role based in the US.

POSITION: Temporary, non-exempt