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Focus Laboratories

Internal Audit QA Manager

Focus Laboratories Cherry Hill Township, New Jersey, United States · $100K–$110K/yr

Biotechnology · 11-50 employees

19 h ago
qa Senior (5-10 yrs) Full-time United States
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About the role

The Internal Audit QA Manager provides independent oversight of laboratory quality and compliance systems to ensure adherence to cGMP and inspection readiness. Responsibilities include performing internal audits, reviewing analytical data, managing CAPA and deviations, and leading a team to drive continuous improvement.

What they look for

Internal Auditing Quality Assurance cGMP Technical Writing Regulatory Compliance Analytical Data Review People Leadership CAPA Deviation Management Inspection Readiness FDA Regulations ICH Guidelines USP Standards ALCOA+ Cross-functional Communication Risk Assessment

Requirements

The role requires senior QA and compliance experience within a regulated laboratory environment such as GMP or ISO 17025. Candidates must possess strong technical writing skills, internal audit expertise, and proven leadership abilities.

Full description

Who We Are

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.

Role Summary

The Internal Audit QA Manager provides independent oversight of TPM’s laboratory quality and compliance systems to support cGMP adherence and inspection readiness. You will evaluate analytical data, validation work, and quality records, and identify compliance risk while driving practical, continuous improvement.

Key responsibilities include: - Perform internal audits and independent QA reviews of protocols, reports, and controlled records - Review/approve analytical data packages and data-release readiness - Assess OOS/OOT, deviations, CAPA, and change controls; conduct trending and recommend actions - Confirm alignment to FDA, ICH, USP, 21 CFR 210/211, ALCOA+ and internal standards - Support client/regulatory audits and provide GMP guidance and training - Lead a team as section head, manage priorities/resources, and partner with Sales and senior leaders

Required qualifications/skills: - Senior QA/compliance experience in a regulated lab environment (GMP/ISO 17025 or similar) - Internal audit expertise; strong technical writing/review skills - People leadership, cross-functional communication, and sound judgment

Apply if you can lead with integrity and keep quality decisions clear and defensible.

Daily Flow

You’ll work onsite in Cherry Hill, NJ, Monday–Friday, 8:30am–5:00pm, balancing planned audit work with real-time quality decisions. The day typically includes focused time reviewing documentation and data in detail, then short, direct discussions with analysts and leaders to confirm facts and close gaps. You’ll keep inspection readiness moving by tracking open items to completion and setting clear priorities for your team. When clients or auditors are on site (or requesting information), you’ll help coordinate responses and keep communication tight and professional. You’ll also spend time aligning with Sales and senior management on upcoming work, timelines, and risk areas so quality oversight supports delivery without surprises.

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