Director, Supplier Quality, Inspection & Audit
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What you'll do
- 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.
- 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.
What they're looking for
- 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
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.
Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.
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
EEOC Statement: Centessa Pharmaceuticals, a wholly owned subdisary 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.
Company
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