Quality Control Manager
Colorcon® is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, specialty excipients and functional packaging for the pharmaceutical, nutritional, and animal health industries. Our best-in-class products and technologies are complemented by our extensive formulation experience, application data and value-added services to support all phases of solid oral dose design, development, and manufacture.
Our focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice. That reputation is based on superior product quality, unparalleled technical support, extensive regulatory assistance and reliable supply from multiple locations, with our Global Headquarters located in Harleysville, Pennsylvania.
Colorcon has 26 technical service laboratories globally and more than 2100 employees exclusively dedicated to its customer base.
We are a successful company thanks to our diverse workforce and global reach. We believe that our operating principles define our culture, values and organizations and are key to achieving our mission and vision, strategies and goals.
Platinum Rule: We treat others the way they want to be treated
Empowerment: We trust our colleagues with responsibility and decision-making
Keep Getting Better: We create an environment for constant improvement, to be the best we can
Teamwork: We embrace the value of collaboration; work together to exceed what is possible as individuals
Customer Focus: We put our customers’ needs at the heart of everything we do
Global Respect: We are citizens of a diverse world and behave with respect for the communities in which we operate
Our People Enjoy a Wide Offering of Employee Benefits, including but not limited to:
- All employees are eligible to participate in our company-wide bonus program
- Employees have the choice between three medical plans
- 100% company-paid Dental Insurance for all employees and their qualifying dependents
- Optional Vision Coverage
- Fitness and Wellness Programs
- Employee Assistance Programs (EAP)
- Corporate Social Responsibility Groups (CSR)
- Parental Leave
- Tuition Reimbursement; up to $8,000 per calendar year
- 401(k) Company Matching
- Paid Time Off
- Paid Holidays
Colorcon is committed to maintaining a diverse workforce and an inclusive and equitable work environment. This includes all employment-related decisions and business dealings on the basis of race, color, ethnicity, national origin, age, sex, sexual orientation, religion, disability, veteran status, or any other legally protected status.
The Quality Control Manager is responsible for leading the Quality Control laboratory in West Point and Harleysville and the incoming sampling functions for the West Point, PA manufacturing facility. This role provides leadership for analytical, raw material, finished products, and stability testing activities to ensure safe, compliant, and reliable support of manufacturing operations and customer requirements.
The Quality Control Manager is accountable for laboratory compliance, efficient operational performance, department leadership, alignment of QC capabilities with current and future business needs, and clear, professional communication with employees, cross-functional partners, customers, and site leadership. This role partners closely with Manufacturing, Quality Assurance, Regulatory, Technical Services, Supply Chain, Engineering, EHS and other site leadership to improve performance, support growth, reduce risk, and ensure the laboratory is positioned to meet evolving business needs. This position reports to the Senior Quality and Regulatory Manager at West Point.
Responsibilities & Duties
- Manage, coach, and develop a team of chemists, microbiologists, analysts, and laboratory personnel, including hiring, training, performance management, development planning, and succession planning.
- Ensure all laboratory activities are performed in compliance with applicable cGMP, cGLP, safety, quality, regulatory, customer, and internal requirements.
- Maintain laboratory data integrity through strong documentation practices, system controls, analyst training, and timely investigation of nonconformances.
- Ensure effective execution of laboratory quality systems including SOP governance, training compliance, deviations, CAPAs, change controls, calibration, and preventative maintenance.
- Own and monitor QC performance metrics, including testing turnaround time, first-time right, calibration and training compliance, and laboratory deviations and nonconformances.
- Partner with manufacturing and quality teams to identify root causes, reduce repeat issues, and improve first-time right performance.
- Develop and execute capacity plans to support production schedules, new business, customer and internal requirements, equipment needs, and future site strategy and growth.
- Ensure stability testing requirements are planned, executed, reviewed, and completed in accordance with applicable procedures.
- Partner with site leadership to resolve issues, support production priorities, improve quality performance, and advance site objectives.
- Identify and lead continuous improvement initiatives to improve laboratory safety, compliance, productivity, utilization, and operational performance.
- Support customer complaint investigations, technical inquiries, internal nonconformance investigations, and other business-critical issue resolution.
- Maintain the QC laboratory in a state of readiness for internal, customer, regulatory, and global audits.
- Build and maintain a laboratory culture focused on safety, compliance, accountability, collaboration, technical excellence, teamwork, and continuous improvement.
Minimum Qualifications
- Bachelor’s degree in a science discipline required.
- Minimum of 5 years of industry experience in a laboratory environment and a minimum of three (3) years of Quality Control management experience required.
- Demonstrated experience leading a technical laboratory team in a regulated manufacturing environment.
- cGMP and cGLP manufacturing experience required.
- Strong knowledge of laboratory quality systems and change control. Experience with electronic laboratory systems and other digital laboratory tools.
- ERP system experience required.
- Experience with analytical testing operations, laboratory instrumentation, method lifecycles, and stability programs.
- Demonstrated ability to lead people, build talent, manage performance, and create an accountable team culture.
- Experience managing and balancing departmental budgets with business and operational needs.
- Experience using metrics, root cause analysis, and continuous improvement tools to improve laboratory performance.
- Ability to balance compliance, customer needs, production priorities, and business growth requirements.
- Strong interpersonal skills with the ability to build relationships and communicate effectively across all levels of the organization. Ability to present technical information clearly to non-technical audiences.
- High level of integrity and commitment to ethical practices in quality and compliance.
- Demonstrated agility in managing change and driving continuous improvement.
- Strong time management, organizational, and decision-making skills required.
Location:
420 Moyer Blvd
North Wales, Pennsylvania, 19486
United States
Colorcon participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the Form I-9.
E-Verify Works for Everyone
For more information on E-Verify, or if you believe that your employer has violated its E-Verify responsibilities, please contact DHS.
