Supplier Quality Assurance Manager
About The Position
The Supplier Quality Assurance Manager owns supplier quality oversight for PharmaLogic’s U.S. PET drug manufacturing operations under 21 CFR Part 212, ensuring suppliers and contract service providers meet CGMP, customer, and company requirements. The role manages the supplier lifecycle, including risk classification, qualification, Quality Agreements, auditing, performance monitoring, change control, and disqualification. It leads a team of quality auditors and participates in the internal audit program. The position reports to the Director, 212 Manufacturing Quality & Regulatory. The manager owns the risk-based supplier quality program in alignment with ICH Q9(R1) and Q10. The program covers raw materials, precursors, components, and contract service providers, including contract testing laboratories, calibration and maintenance providers, and GxP computerized system and software vendors. The role oversees supplier qualification and audits, supplier agreements and changes, supplier issues and corrective actions, supplier performance metrics, and supply continuity risks. It also serves as the supplier oversight subject matter expert during FDA inspections and customer audits.
Requirements
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, Quality Management, or a related scientific discipline.
- At least 7 years of QA experience in an FDA-regulated pharmaceutical environment, including at least 3 years in supplier quality involving qualification, auditing, Quality Agreements, and SCARs.
- At least 3 years of people leadership, including supervising auditors or quality professionals.
- Lead auditor experience and a record of building or managing a risk-based supplier program, including classification, ASL, and scorecards.
- Working knowledge of 21 CFR Parts 210, 211, and 212; ICH Q9 and Q10; and FDA guidance on Quality Agreements.
- Strong analytical, negotiation, and communication skills.
- Ability to travel up to 50%.
Nice To Haves
- ASQ CQA, CSQP, CPGP, or equivalent certification.
- Auditing experience with API, precursor, sterile component, or contract laboratory suppliers.
- Experience with eQMS supplier modules, ERP approved-supplier controls, and FDA inspection support.
- Experience building an audit function, including auditor qualification programs.
Responsibilities
- Own and govern the risk-based supplier quality program, including SOPs, criticality-based supplier classification, the Approved Supplier List (ASL), and eQMS supplier records.
- Lead the audit team by hiring, assigning, developing, and evaluating auditors; setting objectives; conducting performance reviews; and maintaining auditor training, qualification, and requalification.
- Calibrate audit practices across the team and review and approve audit reports for technical accuracy, observation risk classification, and consistency.
- Execute supplier qualification and the annual risk-based audit schedule using questionnaires, desktop reviews, and remote, on-site, and for-cause audits as appropriate to supplier risk and performance.
- Grant quality approval before GMP use, set requalification frequency, track audit observations through CAPA closure, and adjust the schedule based on supplier performance signals.
- Work with Operations and Supply Chain to embed quality requirements in sourcing and purchasing, including material specifications, purchase-order quality clauses, and approval gates for new suppliers, materials, and services.
- Represent Quality in supplier selection decisions and cross-functional supplier improvement initiatives.
- Maintain and periodically review Quality Agreements with applicable suppliers and contract service providers, defining responsibilities for change notification, deviation and OOS reporting, release, records retention, and audit rights.
- Communicate quality and regulatory requirement changes to suppliers.
- Manage supplier non-conformances and SCARs, including supplier-related NCR, OOS, MCR, and deviation investigations; drive root-cause analysis, CAPA, and effectiveness verification.
- Assess product impact and lot-disposition implications with site Quality and record outcomes in supplier performance history.
- Assess supplier change notifications through change control for impact on specifications, validated processes, and regulatory filings.
- Maintain the documented basis for reliance on Certificates of Analysis (COAs), including initial and periodic confirmatory testing of supplier results.
- Maintain supplier and audit program KPIs and scorecards, trend data, report performance and risk to Q&R leadership and Quality Management Review, and recommend conditional approval, probation, or disqualification.
- Assess sole-source and supply-continuity risks for critical materials and define mitigations with Operations and Supply Chain, including secondary-source qualification and contingency plans that account for short half-life and limited inventory constraints.
- Serve as the supplier oversight SME for FDA inspections and customer audits, present the supplier program, and lead responses to supplier-related observations.
- Perform internal GMP audits as assigned while maintaining independence from processes under the role’s control.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
