Director, Supplier Quality, Inspection & Audit (contractor)

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company•Boston, MA

6d•$95 - $120•Remote

About The Position

The Director, Supplier Quality, Inspection & Audit (contractor) 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.

Requirements

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

Responsibilities

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
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.
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.
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.