AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com .
The Quality Control Manager will provide leadership for GMP compliance and quality systems management within Quality Control. This position will provide direction for execution of deviations, CAPAs, and change controls within the Quality Control department. Additionally, the position will oversee QMR and APR deliverables. The ideal candidate will be an expert in laboratory compliance and developing interdepartmental relationships.
- Oversee QC compliance team and provide training to staff
- Provide subject matter expertise to prepare for internal audits and regulatory agency inspections
- Provide oversite of QC responses to audits and inspections and coordinate resulting CAPAs as
- Provide oversite of QC contribution to APR and QMR including metric development
- Oversee laboratory investigations, deviations, and CAPAs
- Oversee quarterly reports for EM/Utilities alerts/actions
- Drive continuous improvement to related processes
- Develop and coach staff in alignment with company goals and individual career aspirations
KNOWLEDGE, SKILLS & ABILITIES:
- Extensive experience with Quality Systems and Regulatory Inspections
- Extensive experience with metric development, monitoring and improvement
- Detailed understanding of data integrity requirements for GMP operations, including 21CFR Part 11
- Demonstrated ability to work effectively on cross-functional teams and engage with external clients
- Strong organizational and project management skills, including technical writing and presentation of technical data.
- BS/BA degree with 5+ years of industry experience, or
- Master’s degree with 3+ years of industry experience. Equivalent education and experience may substitute for stated requirements.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances