Sr. Quality Assurance Supplier/Vendor Management at AGC Biologics

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.

Summary:

The Sr. Quality Systems Scientist, Supplier Management, will support the growing Quality organization by managing the approved supplier program and external audits, raw material quality management and vendor material notifications. This leader also supports their own team, customer project teams and efforts in continuous improvement at AGC Biologics.

KEY RESPONSIBILIES:

• Manage and develop department personnel
• Manage AGC Biologics Approved Supplier Program and List
• Establish and maintain vendor communication as the AGC Biologics point of contact
• Primary contact for scheduling of external audits and follow up on audit findings
• Perform external audits/manage timely performance of audits, i.e. via consultants and other internal qualified resources
• Collaborate with using departments to ensure annual assessment of vendors
• Manage the assessment of vendor material change notifications and the resulting internal AGC changes, as needed
• Develop/optimize and maintain supplier corrective action process
• Work with internal technical authorities and Subject Matter Experts to investigate raw materials discrepancies
• Manage and track investigations related to raw material/consumable discrepancies
• Follow up with supplier to ensure investigation progress, as needed
• Track the approval of new part number requests and material spec changes for multiple projects
• Create and revise controlled documents through paper and web-based GMP systems
• Assists with continuous improvement projects related to process workflow and document control systems for vendor management and raw materials
• Provide guidance and decision making for vendor and supplier program and raw material/part number creations
• Issue metrics as defined by the site
• Other tasks as assigned by Director

KNOWLEDGE, SKILLS & ABILITIES:

• Ability to communicate in a professional, efficient manner at all levels of the company
• Strong attention to detail and assistance with identification and implementation of SCM best practices and industry standards
• Ability to work hours necessary to support production activities
• Proficient in Microsoft Office
• Auditing experience preferred

EDUCATION/EXPERIENCE:

• BS/BA degree in a scientific discipline, such as Biology, Chemistry, Pharmaceutics, etc.
• 12+ years of experience in Supplier Quality Management or a combination of Supplier/Materials/Operations Management and Quality Assurance/Quality Systems
• Certified Auditor preferred
• 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.