Location
Oklahoma | United States
Job description
QC Program Manager
**Must relocate to Oklahoma City**
We have partnered with a promising startup that provides an extensive array of development services, spanning pre-clinical cell line expression, process and analytical development, to late-stage process characterization. The company boasts a highly skilled Executive Leadership team with a stellar track record, featuring professionals who have previously held key positions in globally recognized organizations such as Lonza, AstraZeneca, and Merck.
THE ROLE:
- Lead and oversee quality control projects, ensuring successful execution within defined timelines and budgets.
- Collaborate with cross-functional teams to establish project goals, milestones, and deliverables.
- Conduct data analysis and generate reports to support product shelf life determination and storage conditions.
- Develop, implement, and manage a comprehensive stability program to assess product stability over time.
- Collaborate with vendors to ensure the quality and compliance of supplied materials and services.
- Establish and maintain strong relationships with vendors, conducting regular assessments and audits.
- Drive the development, review, and maintenance of product and raw material specifications.
- Oversee the successful transfer of analytical methods between development, validation, and quality control laboratories.
- Ensure documentation, training, and execution of method transfer protocols meet quality and regulatory standards.
- Ensure compliance with cGMP, ISO, and other relevant quality standards and regulatory requirements.
- Identify opportunities for process improvement within the quality control function.
ABOUT YOU:
- B.S. in relative scientific field and 4+ years of experience in QC within the biotechnology or pharmaceutical industry.
- Project management experience with a focus on QC operations.
- Strong knowledge of stability programs, vendor management, specification development, and method transfer processes.
- Familiarity with cGMP, ISO, and other relevant quality standards and regulatory requirements.
If interested, please send your CV to [email protected] or apply directly to this job advert.
Job tags
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