Quality Assurance Manager
About The Position
TPM Laboratories, Inc. is an independent contract testing laboratory providing personalized analytical services to the pharmaceutical and chemical industries. TPM Labs specializes in Analytical Research and Development Testing Services, Quality Control Testing and Stability Storage & Testing Services. Our goal is to provide high quality, cost effective and timely service, personalized to meet your needs. The QA Manager leads TPM Laboratories’ quality system and ensures laboratory work meets cGMP, FDA, ICH, USP, and internal requirements. This role exists to protect data integrity, keep the site inspection-ready, and provide clear QA governance across documentation, investigations, and releases.
Requirements
- Bachelor’s in Chemistry (or related discipline)
- 6–8 years in a regulated pharmaceutical/laboratory environment
- Strong QA systems, audit, and compliance oversight experience
- Proven review/approval of scientific and regulatory documentation
- People leadership experience
- Strong knowledge of ALCOA+ and 21 CFR 210/211
Nice To Haves
- Ability to set direction
- Ability to make sound quality decisions
- Ability to lead a compliant, audit-ready lab
Responsibilities
- Leading QA staff
- Maintaining QA policies, SOPs, and controlled documents
- Approving methods, specifications, and validation protocols
- Reviewing analytical data for accuracy and compliance
- Overseeing OOS/OOT, deviations, CAPA, and change control
- Trending quality events
- Managing internal audits
- Supporting client and regulatory audits
- Driving GMP training and continuous improvement
- Checking the status of open quality events and the lab’s inspection-readiness items
- Confirming priorities with senior leadership
- Document review—data packages, controlled records, and technical reports
- Conducting team touchpoints
- Problem-solving sessions to align QA expectations with operational realities
- Hosting or preparing for a client audit
- Reviewing responses and commitments
- Briefing teams on a regulatory update
- Confirming resources and schedules
- Ensuring projects are logged correctly in Pryme
- Identifying practical improvements to strengthen compliance without slowing delivery
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What This Job Offers
Job Type
Full-time
Career Level
Manager
