Quality Assurance Manager

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

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.

Scope of the Role

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.

Required Qualifications/skills

• 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

Your Typical Day

You start by checking the status of open quality events and the lab’s inspection-readiness items, then confirm priorities with senior leadership. Mid-morning is focused time for document review-data packages, controlled records, and technical reports—so releases and client timelines stay on track.

As the day moves on, you shift between short, agenda-led team touchpoints and deeper problem-solving sessions where you align QA expectations with operational realities. You may host or prepare for a client audit, review responses and commitments, or brief teams on a regulatory update.

Before the day ends, you look ahead: confirm resources and schedules, ensure projects are logged correctly in Pryme, and identify one practical improvement to strengthen compliance without slowing delivery.