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.
The Sr. Manager/Manager, Quality Systems is a full-time position located at the AGC Biologics facility located in Longmont, Colorado supporting both Colorado facilities (Longmont and Boulder). The primary focus for this role is to lead the Quality Systems team to ensure site level Quality Systems are appropriately designed, implemented and measured for cGMP compliance and effectiveness. Area of responsibilities include Change Control, Deviation and CAPA Management, Data Integrity and Quality Management Review. The position has the ability to grow and mature the current quality systems and tools and develop team and staff members.
- Collaborate and contribute to the writing and review of corporate Quality Systems Policies and associated Standard Operating Procedures (SOPs) for Deviations, CAPA and Change Control. Ensure local implementation of corporate policies and SOPs as appropriate.
- Ensure local procedures and processes are in place for Deviations, CAPA, Change Control, Data Integrity and Quality Management Review.
- Develop and maintain documentation to track Quality System information.
- Report key performance metrics for Quality Systems.
- Drive continuous improvement in Quality Systems; network within AGC to understand and implement best practices and drive alignment.
- Facilitate Quality Management Review.
- Support use of electronic QMS system; understand operation, train users, develop tools for users.
- Supports regulatory inspections as an SME for core Quality Systems
- Provide training and guidance to staff and site regarding core Quality System requirements.
- Represent the Quality unit at various project meetings and provide quality input in the resolution of Quality System related issues.
- Work to develop a high performing team delivering performance at a high degree of accuracy.
- Engage in Corporate Quality initiatives and represent CO Sites.
- May act as a delegate for Director Quality Systems, Manager Supplier Quality, Training Supervisor and Document Control Supervisor.
KNOWLEDGE, SKILLS & ABILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Strong knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products including, but not limited to, ICH Q7, ICH Q10, 21 CFR 210 and 211, 21 CFR Part 11, 21 CFR 600 and 610. Must be self-motivated, organized and proactive.
- Proven experience successfully managing multiple projects simultaneously that requires cross-functional collaboration.
- Demonstrated ability to build effective working relationships across departments (MSAT, Process Development, Project Management and Business Development) to support new processes and products.
- Demonstrated experience leading troubleshooting efforts, including root cause analysis.
- Proven technical writing skills.
- Skilled in verbal communications. Ability to respond to complex inquiries or complaints from customers, co-workers and supervisors regarding products and processes.
- Strong presentation skills.
- Skilled in time and priority management. Must be able to work under general to minimal direction to manage team and complete work tasks.
- BS in Life Sciences discipline such as Biochemistry, Chemistry, Biology or related field required
- Minimum of 8+ years of experience in the biotechnology or pharma industry with experience in biologics
- Minimum of 5+ years of experience in managing professional level staff
- Strong application experience and thorough understanding of Quality Systems and risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices.
- Experience with relevant analytical lab equipment and computers.
- Must have experience writing, reviewing, approving and managing GMP documentation.
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