The Director, Quality Management Systems is responsible for establishing and maintaining quality systems, supportive procedures, work instructions or guidance documents that enable the sites to comply with applicable regulatory requirements and expectations, while also helping build a Quality Culture internal to the company. This role will directly be responsible for ensuring the quality systems enable, facilitate compliance at the CPH site and are scaled to support the different manufacturing and phase needs.
- Manage and maintain GMP Quality System consistent with regulatory requirements and industry best practices
- Design and maintain Quality Systems for GMP Deviations, CAPA, Training, Periodic Change Management, Review and Document Management programs.
- Manage Quality System Reporting
- Develop and maintain Quality System Metrics
- Administer Quality Management Review program
- Ensure continuous improvement of Quality Systems
- Support Regulatory and Client Audits
- Proactively address GMP compliance concerns and resolve problems
- Work on complex problems that involve groups outside of QA as well as clients
- Partner with other departments/groups for corrections and problem solving
- Review and approve deviations and corrective actions
- Participate in GMP-related problem resolution
- Provides direct supervision and staff development
- Establish departmental goals and priorities, assign tasks and projects to staff
- Use best practices in training development and coaching
- Host and lead regulatory inspection and client audit readiness
- Maintain internal audit program
- Maintain supplier quality management program, including the creation of specifications
Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/ Biotechnology Industry
- Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations
- Strong interpersonal, written and oral communication skills
- Strong problem solving skills
- M.Sc. in chemistry or life sciences or equivalent experience
- 10+ years of relevant experience in a pharmaceutical or FDA/GMP environment
- Direct Experience leading GMP Quality Systems development, implementation, and continuous improvement
- Experience hosting and leading client and Regulatory Inspections
- Management experience, including a demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated
Please be aware that we take in consideration only the applications send via our career page and, not via email. We will process the applications as they arrive.
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.