Quality Control Manager, Pharmaceutical & cGMP
Overview
Own the Quality Control laboratory at Colorcon's West Point and Harleysville sites, leading a team of chemists and microbiologists to ensure safe, compliant, and reliable support of manufacturing operations. This role drives laboratory compliance, operational performance, and team development while aligning capabilities with business growth. Partner with cross-functional teams including Manufacturing, Quality Assurance, and Regulatory to reduce risk and improve quality performance. The position reports to the Senior Quality and Regulatory Manager, offering a visible leadership opportunity in a global pharmaceutical supplier. This role stands out for its focus on continuous improvement and building a culture of accountability and technical excellence.
What You'll Do10
- 1Lead and develop a team of chemists, microbiologists, and analysts through hiring, training, performance management, and succession planning.
- 2Ensure laboratory activities comply with cGMP and cGLP standards, safety regulations, and internal quality systems.
- 3Maintain data integrity by enforcing strong documentation practices, system controls, and timely investigation of nonconformances.
- 4Drive effective execution of laboratory quality systems, including SOP governance, training compliance, CAPAs, and change controls.
- 5Monitor and improve key QC metrics like turnaround time, first-time right, and calibration compliance to enhance performance.
- 6Develop and execute capacity plans to support production schedules, new business, and future site growth.
- 7Oversee stability testing programs to ensure timely execution and compliance with procedures.
- 8Collaborate with site leadership to resolve issues, improve quality performance, and advance strategic objectives.
- 9Lead continuous improvement initiatives to boost laboratory safety, productivity, and utilization.
- 10Maintain audit readiness for internal, customer, regulatory, and global inspections.
Requirements10
- 1Bachelor's degree in a science discipline required.
- 25+ years in a laboratory environment with 3+ years of Quality Control management experience.
- 3Demonstrated experience leading a technical laboratory team in a regulated manufacturing environment.
- 4cGMP and cGLP manufacturing experience required.
- 5Strong knowledge of laboratory quality systems and change control.
- 6Experience with electronic laboratory systems and ERP systems.
- 7Expertise in analytical testing operations, instrumentation, method lifecycles, and stability programs.
- 8Proven ability to build talent, manage performance, and create an accountable team culture.
- 9Skilled in using metrics, root cause analysis, and continuous improvement tools like Lean or Six Sigma.
- 10Strong interpersonal and communication skills, with ability to present technical information to non-technical audiences.
Salary Insight
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