Quality Manager Jobs

About The Position

Requirements

• Bachelor's degree in supply chain management, quality assurance, pharmaceutical sciences, or a related field (or equivalent practical experience)
• 4+ years of experience in supply chain quality, vendor quality assurance, or supplier auditing, ideally within pharmaceutical, compounding, or regulated manufacturing environments
• Deep familiarity and working knowledge of FDA 503A/503B regulations, USP compounding standards, and cGMP principles as they apply to suppliers and incoming materials
• Skilled at running structured audits and translating findings into clear, actionable corrective action plans
• Detail-oriented and comfortable owning documentation-heavy processes (CoAs, qualification files, audit reports) that need to hold up under regulatory scrutiny
• A collaborative operator who can work cross-functionally with procurement, compliance, and operations without slowing down the business
• Proven track record managing CAPA processes, including root cause analysis and effectiveness verification
• Demonstrated experience conducting supplier audits (on-site or remote) and managing vendor qualification/re-qualification processes

Nice To Haves

• Certified or working toward certification (ASQ CQA, CSQP, or equivalent) is a plus, but hands-on audit experience matters more than the credential
• Experience working with 503A or 503B compounding pharmacies, across multi-state/multi-site pharmacy networks (Texas, Alabama, California a plus), and/or FDA-regulated manufacturing
• ASQ Certified Quality Auditor (CQA), Certified Supplier Quality Professional (CSQP), or equivalent certification
• Familiarity with API and packaging component sourcing, including CoA review, FEI/facility registration verification, and distributor vs. manufacturer qualification
• Hands-on experience with NetSuite, Ramp, or ComplianceQuest (or similar ERP/spend management/QMS platforms) for supplier and quality data tracking
• Experience navigating state board of pharmacy requirements as they relate to supplier compliance
• Background in building or scaling a supplier quality function from the ground up, rather than just operating within an established one

Responsibilities

• Lead supplier qualification and ongoing audit programs across API, excipient, and packaging vendors, including on-site and remote audits, documentation review, and risk-tiered qualification criteria
• Own the Approved Vendor List (AVL) process, managing hard-gate compliance checks (FDA facility registration, CoA traceability, USP monograph compliance) and periodic requalification cycles
• Conduct supplier scorecards and performance evaluations covering quality metrics, delivery reliability, non-conformance rates, and corrective action responsiveness
• Manage CAPA (Corrective and Preventive Action) processes for supplier-related quality deviations, tracking root cause analysis and verification of effectiveness
• Ensure supplier and incoming material compliance with applicable state board and USP standards (e.g., USP <795>, <797>, <800>, <1079>) across multi-state pharmacy operations
• Partner with procurement and compliance teams to maintain audit-ready documentation, support regulatory inspections, and drive continuous improvement in vendor quality standards
• Other duties as assigned.

Benefits

• Medical, Dental, and Vision plans
• Flexible Spending/Health Savings Accounts
• Flexible PTO
• 401(k) + Company Match
• Life Insurance
• Pet insurance