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.
Similar Jobs
Artificial Intelligence • Cloud • Fintech • Information Technology • Insurance • Financial Services • Big Data Analytics
Oversee field and general office budgeting, occupancy and lease financial activities, rent and expense analysis, agency meeting budgets, and financial reporting. Partner with field teams, real estate, legal, vendors, and consultants to monitor spending, maintain lease records, resolve issues, and support decision-making. Coordinate deliverables, review financial processes, and develop remediation plans while supporting ad hoc initiatives.
Top Skills:
AnaplanOne View Leasing AdminSAPTableau
Artificial Intelligence • Cloud • Fintech • Information Technology • Insurance • Financial Services • Big Data Analytics
Investigate and administer life insurance claims, determine customer eligibility, apply contractual and legal provisions, and process covered payments up to $60,000. Communicate claim decisions and status updates to customers, beneficiaries, employers, and business partners through phone and email. Gather and analyze information, identify necessary medical records, meet processing and performance standards, follow compliance procedures, and manage high claim volumes and changing priorities.
Top Skills:
ExcelMicrosoft OutlookMicrosoft PowerpointMicrosoft SharepointMicrosoft TeamsMicrosoft Word
Artificial Intelligence • Information Technology • Machine Learning • Natural Language Processing • Productivity • Software • Generative AI
Build Superhuman Mail’s AI platform, including MCP tools and standards, agentic workflows, personalization, LLM evaluation systems, and model-selection strategies. The role involves shipping production LLM features, partnering across teams on reusable AI capabilities, and potentially shaping data collection and modeling approaches. Engineers will work primarily with backend systems and applied AI while adapting quickly to evolving technologies and product priorities.
Top Skills:
AnthropicAWSGoKubernetesLlmsMcpOpenaiPostgresPythonRedisTurbopufferTypescript
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
