Quality Manager

Quality 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 we 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.

Responsibilities:

• Implement and improve the system management for the ISO 9001 and ISO 15378.
• Lead the risk analysis team. (lead FMEA or HACCP team) and ensure the follow up.
• Ensure cGMP rules adapted to our business are implemented, respected.
• Manage documents into GMS.
• Responsible for GMP and IPC training, and responsible training efficiency.
• Ensure customers' requirements are well defined. Validate Customer Quality Agreements and questionnaires.
• Lead customer complaints (CAPA), CAPA team.
• Independent from production (functional link with the head of Quality), allowed to stop production.
• Lead customer audits, and is responsible for audits follow up (CAPA).
• Lead improvements and ensure that root cause analysis methodology is well applied.
• Manage and document handling of returns and restricted materials.
• Acts as site management representative .
• Escalate a risk of recall to upper management and the criteria for recall.
• Can escalate any issue (internal or external) to the upper management (head of quality).
• Lead and coach QA/QC team.
• Responsible for people development (evaluation, training, talent identification…)
• Coordinate regulatory affairs with Product Stewardship for the plant.
• Lead at global level the change control process (e.g. SOP, quarterly global conf call).
• Support the Head of quality for system management improvements (e.g. SOPs).
• Auditor for system audits.

• Bachelor's degree in engineering discipline or quality.
• 5 years' experience in Quality and people management.
• Experience in Lean Sigma methodology, 8D methodology, ISO 15378 preferred.
• Fluent in spoken and written English.

Location:
101 Christine Dr.
Belen, New Mexico, 87002
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.
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For more information on E-Verify, or if you believe that your employer has violated its E-Verify responsibilities, please contact DHS.