Quality Assurance Manager of Internal Audits

FOCUS - A Cormica Lab; New Jersey; On-site; USD 110,000 - 150,000; Full time

Job summary

TPM Laboratories, Inc. in Cherry Hill, NJ seeks an Internal Audit QA Manager to provide independent oversight of quality and compliance systems, supporting cGMP adherence and inspection readiness. You will evaluate analytical data, validation work, and quality records, driving practical improvements.

The role requires senior QA experience, internal audit expertise, and strong leadership to guide cross-functional teams and coordinate with Sales and senior management during audits and inspections.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP/ISO 17025

Internal auditing

People leadership

Job 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

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.