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 and cell and gene therapies. 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 Management Systems Sr. Manager is responsible and accountable for managing the development and implementation of AGC Biologics Global Quality System across regions, sites, and supporting organizations. The position will be specifically responsible for leading the following key activities within the Quality Systems management program:
- Support the development of AGC Biologics corporate policies and procedures that form the basis of the internal of the internal global quality management system, this includes developing processes for global quality agreements, guidance documents or other systems
- Support sites with the establishment of Global Owners of key sub-systems and quality systems focus groups/forums
- Support the deployment of global IT solutions to enable the consistent use of quality systems
- Support sites with the execution of their Quality Management Review meetings
- Lead Quality Risk Management activities
- Support the development, definition and rationalization of Global Quality Metrics Establish and manage a Global Quality Culture program
- Support Global Data Integrity Program initiatives
- Ensure expertise in GMP and Quality Standards is maintained through involvement in Industry forums and conferences
- Develop and execute strategic initiatives for continuous improvement of AGC Biologics Quality System
- Support the execution or follow-ups related to corporate audits/assessments
- Conduct pre-inspection “mock” audits as needed as part of the compliance assessment program.
- Advise and support sites in the management of regulatory inspections and other quality management system programs.
KNOWLEDGE, SKILLS & ABILITIES:
- Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements into effective global procedures/policies.
- Subject matter expertise in global regulatory requirements and expectations as defined by pharmaceutical regulatory authorities.
- Experience performing audits and hosting regulatory inspections.
- Excellent facilitation and project management skills, with strong verbal and written communication skills.
- Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.
- Must be capable of effectively presenting information to senior management, peers, clients and regulatory authorities
- 7+ years of experience in biotech and/or pharmaceutical manufacturing
- 7+ years of experience in quality operations (QA, QC, Quality Systems) within biopharmaceutical and/or pharmaceutical industry
- 5+ years of experience in global or corporate Quality function
- Strong strategic understanding and working knowledge of Quality Systems (FDA QSIT and ICH Q10) and how those systems are implemented to meet FDA, EMA and other major jurisdictional requirements
- Exceptional customer interface skills are required
- Ability to work hours necessary to support global network needs
- Technical background in protein development is preferred
- Requires bachelor or advanced degree or equivalent combination of education and experience
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.