Senior Manager, QA Compliance

About the role

The Senior Manager of QA Compliance is responsible for developing, implementing, and continuously improving the company’s Quality Management System (QMS). This role ensures that manufacturing and operational processes comply with applicable regulatory requirements, industry standards, and internal quality procedures.

This position oversees quality systems, including CAPA, deviations, change control, document control, audit programs, and validation activities. The role partners cross-functionally with Manufacturing, Supply Chain, and Product Development to maintain compliance and strengthen quality processes.

This position reports to the Director of Quality and the requirement is to be onsite in our Somerset, NJ campus five days per week.

Key Responsibilities

Quality Systems Management

• Own and maintain the company’s Quality Management System (QMS) including quality policies, procedures, and documentation standards. • Oversee document control and ensure compliance with Good Documentation Practices (GDP).

Quality Programs Manage core quality system processes, including:

• Non-Conformance Reports (NCR) • Corrective and Preventive Actions (CAPA) • Deviations and investigations • Change Control • Product rework and retrieval (mock recall)

Audit & Compliance

• Lead the internal audit program and coordinate external audits, including ISO, GMP, and customer audits. • Ensure audit readiness and drive corrective actions from audit findings.

Qualification &…