Senior Quality Assurance Leader, Ops & Compliance

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

Benefits offered by this job

Total Rewards package

Job summary

Keenova seeks aSenior Manager, Quality Assurance to oversee Quality Operations and Quality Systems at our Cranbury, NJ site, ensuring compliance with cGMP, FDA regulations, and global standards. You will lead quality floor operations, material disposition, and batch release while driving continuous improvement across facilities.

The role requires 8+ years in QA/Quality Systems with 3-5 years in leadership, familiarity with regulatory inspections, and strong collaboration across departments.

Qualifications

• Bachelor's degree in a scientific, engineering, or related technical discipline.
• 8+ years of progressive experience in Quality Assurance, Compliance, and Quality Systems.
• Biologics, biotechnology, and/or pharmaceutical or biopharmaceutical experience.
• 3-5 years of people leadership experience.
• Experience in maintaining cGMP compliance and regulatory inspections.
• Knowledge of quality systems including CAPA, deviations, change control, risk management, and training.

Responsibilities

• Oversee Quality Operations and Quality Systems to ensure compliance and continuous improvement.
• Lead manufacturing floor quality support, material disposition, and batch release activities.
• Support regulatory inspections, customer audits, and internal audits; ensure inspection readiness.
• Develop, implement, and maintain QA procedures and training programs.

Skills

Leadership presence

Communication skills

Analytical thinking

Project management

Problem solving

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Job description

Keenova seeks aSenior Manager, Quality Assurance to oversee Quality Operations and Quality Systems at our Cranbury, NJ site, ensuring compliance with cGMP, FDA regulations, and global standards. You will lead quality floor operations, material disposition, and batch release while driving continuous improvement across facilities.

The role requires 8+ years in QA/Quality Systems with 3-5 years in leadership, familiarity with regulatory inspections, and strong collaboration across departments.