Quality Assurance Manager
About The Position
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.
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
- Ability to set direction
- Ability to make sound quality decisions
- Ability to lead a compliant, audit-ready lab
Responsibilities
- Leads TPM Laboratories’ quality system and ensures laboratory work meets cGMP, FDA, ICH, USP, and internal requirements.
- Protects data integrity, keeps the site inspection-ready, and provides clear QA governance across documentation, investigations, and releases.
- Leads QA staff.
- Maintains QA policies, SOPs, and controlled documents.
- Approves methods, specifications, and validation protocols.
- Reviews analytical data for accuracy and compliance.
- Oversees OOS/OOT, deviations, CAPA, and change control.
- Trends quality events.
- Manages internal audits.
- Supports client and regulatory audits.
- Drives GMP training and continuous improvement.
- Checks the status of open quality events and the lab’s inspection-readiness items.
- Confirms priorities with senior leadership.
- Reviews document packages, controlled records, and technical reports.
- Conducts team touchpoints.
- Leads problem-solving sessions to align QA expectations with operational realities.
- Hosts or prepares for client audits.
- Reviews responses and commitments.
- Briefs teams on regulatory updates.
- Confirms resources and schedules.
- Ensures projects are logged correctly in Pryme.
- Identifies practical improvements to strengthen compliance.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
