Quality Assurance Manager

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.

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:
- Bachelors in Chemistry (or related discipline)
- 68 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.

You start by checking the status of open quality events and the labs inspection-readiness items then confirm priorities with senior leadership. Mid-morning is focused time for document reviewdata packages controlled records and technical reportsso 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.

Required Experience:

Manager