QA Leader: GMP & Compliance for Pharmaceutical Lab

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

Job summary

TPM Laboratories, Inc. is a dedicated contract testing lab seeking a QA Manager to lead the quality system and ensure cGMP compliance. You will protect data integrity, maintain inspection readiness, and govern documentation, investigations, and releases.

The role requires managing QA staff, approving methods and validation protocols, and driving continuous improvement while supporting client and regulatory audits.

Qualifications

• 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.

Responsibilities

• Lead QA staff; maintain QA policies, SOPs, and controlled documents.
• Approve methods, specifications, and validation protocols.
• Review analytical data for accuracy and compliance; oversee OOS/OOT, deviations, CAPA, and change control.
• Trend quality events; manage internal audits; support client and regulatory audits.
• Drive GMP training and continuous improvement.

Skills

QA leadership

Audit

ALCOA+

21 CFR 210/211

GxP

Regulatory docs

Data integrity

CAPA

Education

Bachelor's in Chemistry

Job description

TPM Laboratories, Inc. is a dedicated contract testing lab seeking a QA Manager to lead the quality system and ensure cGMP compliance. You will protect data integrity, maintain inspection readiness, and govern documentation, investigations, and releases.

The role requires managing QA staff, approving methods and validation protocols, and driving continuous improvement while supporting client and regulatory audits.