QA Senior Manager: cGMP, Compliance & Inspections

Mallinckrodt Pharmaceuticals; Cranbury Township (NJ); On-site; USD 151,000 - 241,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Keenova seeks a Senior Manager, Quality Assurance to lead quality operations and systems at the Cranbury, NJ and Rye, NY facilities, ensuring cGMP compliance and FDA-aligned quality practices. You will direct manufacturing floor quality, material disposition, batch release, and continuous improvement initiatives.

The role requires 8+ years in QA, 3–5 years of people leadership, and experience with biologics/aseptic operations. Domestic/international travel may be required.

Qualifications

• 8+ years of progressive experience in Quality Assurance, Compliance and Quality Systems within pharma.
• Experience with biologics, biotechnology or biopharmaceutical operations.
• 3–5 years of people leadership experience.

Responsibilities

• Oversee Quality Operations including manufacturing floor quality support, material disposition, and batch release.
• Direct deviation investigations, CAPAs and effectiveness monitoring.
• Lead regulatory inspections and audits; maintain inspection readiness.
• Maintain and improve the Quality Management System and quality training programs.

Skills

Leadership

Communication

QA Systems

Regulatory Affairs

Quality Analysis

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Job description

Keenova seeks a Senior Manager, Quality Assurance to lead quality operations and systems at the Cranbury, NJ and Rye, NY facilities, ensuring cGMP compliance and FDA-aligned quality practices. You will direct manufacturing floor quality, material disposition, batch release, and continuous improvement initiatives.

The role requires 8+ years in QA, 3–5 years of people leadership, and experience with biologics/aseptic operations. Domestic/international travel may be required.