Director, Supplier Quality, Inspection & Audit (contractor)

Key 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
• Maintain oversight 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

Pay

The hourly range for this position is $95.00 to $120.00 per hour. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

Benefits

Contractors engaged through Centessa are employed through a third-party agency that serves as the employer of record and provides access to a comprehensive benefits package. Eligible contractors may enroll in medical plans, including PPO and EPO options, as well as dental and vision coverage after 30 days. Additional perks, such as a 401(k), wellness programs, and other discounts, may also be available to eligible contractors.

Work Location

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

Position

Temporary, non-exempt

EEOC Statement

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.