Scope of the Role
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.
Key responsibilities include 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; and driving GMP training and continuous improvement.
Required qualifications/skills:
- 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
Apply if you can set direction, make sound quality decisions, and lead a compliant, audit-ready lab.
Your Typical Day
You start by checking the status of open quality events and the lab's inspection-readiness items, then confirm priorities with senior leadership. Mid-morning is focused time for document review-data packages, controlled records, and technical reports-so releases and client timelines stay on track.
As the day moves on, you shift between short, agenda-led team touchpoints and deeper problem-solving sessions where you align QA expectations with operational realities. You may host or prepare for a client audit, review responses and commitments, or brief teams on a regulatory update.
Before the day ends, you look ahead: confirm resources and schedules, ensure projects are logged correctly in Pryme, and identify one practical improvement to strengthen compliance without slowing delivery.
