Product Quality Manager
My client is a global pharmaceutical company focused on developing medicines to treat substance use disorders, as well as serious mental illnesses such as schizophrenia. Not only are they looking to create products to help with these issues, but they are actively working on transforming addiction from a global human crisis to a recognized and treated disease.
This role is responsible to plan, coordinate, lead and manage the activities of the Operational Quality Section within the North American region. This position reports directly into the Head of Quality Operations of North America.
- Develops and leads the Product Quality team to ensure proper roles and responsibilities; development of personnel; and to ensure collaboration across all supported functions.
- Maintain Inspection Readiness procedures for all North American CMOs.
- Ensure that processes needed for the Quality Management System (QMS) are established, implemented, maintained, as agreed with the line manager and in conjunction with current country specific regulatory requirements.
- Co-ordinate and ensure appropriate host for external inspections by Regulatory Authorities. Ensure all external audit findings are formally closed out.
- Perform QMS Review as per SOP to ensure continuing suitability, adequacy and effectiveness of the QMS. Assess opportunities for improvement and the need for changes to the QMS.
- Other Operational Activities as needed, including participating in and providing quality input to project teams supporting new product launches
- Bachelor's degree in relevant scientific discipline
- 5+ years of quality experience in a FDA regulated industry - limited to pharmaceutical, biotech, and medical device industries
- Aseptic manufacturing experience
- Injectable manufacturing experience
- Incredibly competitive compensation package
- Stock purchase plans and 401K
- Comprehensive medical, dental, vision, life, and disability insurance
- Other voluntary benefits
If this sounds like something that you would be interested in, don't hesitate to apply! Looking forward to seeing your CV.