Job Title : Quality Assurance Product Manager
Summary : Are you looking to join a global leader in pharmaceutical synthesis and specialty ingredients? My client is a billion-dollar CDMO that provides both biotech and pharmaceutical companies with expertise and capacity to develop and manufacture active pharmaceutical ingredients (APIs), intermediates and drug delivery solutions at any stage between research and commercial scale. My client also specializes in medical-grade polymer synthesis, flow chemistry and bio-catalysts. If you are someone who is looking for an opportunity to build and develop your own team and quality process, this would be a great opportunity for you!
The Quality Assurance Product Manager will be responsible for :
- Providing hands on leadership to the Quality Assurance Operations team.
- Conducting GMP document review, including procedures, work instructions and new Batch Records.
- Managing review and approval of the executed batch production, analytical control records and specification and stability data.
- Manage release of API's for distribution.
- Conducting quality investigations and reviewing corrective action plans for adequacy and compliance, including root cause analysis and product impact assessments.
- Participation in internal/external audits, self-inspection and regulatory inspections.
- Lead and facilitate continuous improvement efforts
The Quality Assurance Product Manager should have the following requirements :
- Bachelor's Degree in a life sciences related discipline. Higher education preferred
- At least 8 years of experience in a related pharmaceutical role.
- At least 3 years of direct experience with batch record review and product release.
- Working knowledge of GMP regulations used to produce API.
If this sounds like something you would be interested in, please apply!