Owns supplier quality oversight for U.S. PET drug manufacturing operations. Manages supplier qualification, risk classification, audits, Quality Agreements, SCARs, CAPAs, change control, COA reliance, supplier performance metrics, and supply continuity risk. Leads quality auditors, supports sourcing and regulatory inspections, conducts internal GMP audits, and ensures compliance with CGMP, FDA regulations, and applicable ICH guidance.
Supplier Quality Assurance Manager
The Supplier Quality Assurance Manager owns supplier quality oversight for PharmaLogic’s U.S. PET drug manufacturing operations (21 CFR Part 212), ensuring suppliers and contract service providers meet CGMP, customer, and company requirements. The role manages the supplier lifecycle (risk classification, qualification, Quality Agreements, auditing, performance monitoring, change control, and disqualification), leads a team of quality auditors, and participates in the internal audit program.
The position reports to the Director, 212 Manufacturing Quality & Regulatory.
Essential Duties & Responsibilities- Own the risk-based supplier quality program in alignment with ICH Q9(R1) and Q10, including governing SOPs, criticality-based supplier classification, the Approved Supplier List (ASL), and eQMS supplier records. Scope covers raw materials, precursors, components, and contract service providers, including contract testing laboratories, calibration and maintenance providers, and GxP computerized system and software vendors.
- Lead the audit team: hire, assign, develop, and evaluate auditors; set objectives and conduct performance reviews; maintain the auditor training, qualification, and requalification program; 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, applying questionnaires, desktop review, and remote, on-site, and for-cause audits based on supplier risk tier and performance history. Grant quality approval prior to GMP use, set re-qualification frequency, track audit observations through CAPA closure, and adjust the schedule in response to performance signals.
- Embed quality requirements in sourcing and purchasing with Operations and Supply Chain, including material specifications, purchase order quality clauses, and quality approval gates for new suppliers, materials, and services; represent Quality in supplier selection decisions and cross-functional supplier improvement initiatives.
- Maintain Quality Agreements with applicable suppliers and contract service providers consistent with FDA guidance, defining responsibilities for change notification, deviation and OOS reporting, release, records retention, and audit rights; manage periodic review and communicate quality and regulatory requirement changes to suppliers.
- Manage supplier non-conformances and SCARs, including supplier-related NCR/OOS/MCR/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.
- Control supplier changes and COA reliance: assess supplier change notifications through change control for impact on specifications, validated processes, and regulatory filings; maintain the documented basis for COA reliance, including initial and periodic confirmatory testing of supplier results, consistent with 21 CFR Parts 211 and 212 and site procedures.
- Maintain supplier and audit program KPIs and scorecards (e.g., lot acceptance rate, non-conformance and SCAR rates, on-time CAPA closure, audit schedule adherence); 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 risk for critical materials (e.g., radionuclides, precursors, kits, sterile components, synthesis cassettes); 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 supplier oversight SME for FDA inspections and customer audits, presenting the supplier program and leading responses to supplier-related observations; perform internal GMP audits as assigned, maintaining independence from processes under the role’s control.
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, Quality Management, or a related scientific discipline.
- 7+ years of QA experience in an FDA-regulated pharmaceutical environment, including 3+ years in supplier quality (qualification, auditing, Quality Agreements, SCARs).
- 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 (classification, ASL, 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.
- Travel up to 50%.
- 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.
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