Senior QA & Internal Audit Leader (GMP)

Focus Lab

Cherry Hill Township (NJ)

On-site

USD 110,000 - 150,000

Full time

8 days ago
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Job summary

TPM Laboratories, Inc. is seeking an Internal Audit QA Manager to provide independent oversight of laboratory quality and compliance systems to support cGMP adherence and inspection readiness.

You will evaluate analytical data, validation work, and quality records, identify compliance risks, and drive practical, continuous improvement. You will evaluate analytical data, validation work, and quality records, identify compliance risks, and drive practical, continuous improvement.

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

QA compliance
Internal audit
People leadership
Cross-functional communication
Sound judgment

Job description

TPM Laboratories, Inc. is seeking an Internal Audit QA Manager to provide independent oversight of laboratory quality and compliance systems to support cGMP adherence and inspection readiness.

You will evaluate analytical data, validation work, and quality records, identify compliance risks, and drive practical, continuous improvement. You will evaluate analytical data, validation work, and quality records, identify compliance risks, and drive practical, continuous improvement.

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