The Quality Assurance Manager is responsible for providing Quality Assurance leadership and management support to the site. This role ensures the implementation of the site’s Quality Management Systems, ensuring its compliance with applicable regulations and guidelines as well as Corporate Quality policies. It also manages the operational function of the Quality Assurance team and acts as a mentor to its team members. Additionally, this role will support cross functional teams making data driven and highly technical decisions in a timely manner, providing the necessary support or resources to carry out those decisions. This role will play a key role in creating and maintaining a culture of quality, compliance, safety, service, and cost initiatives.
Essential Job Functions:
1. Manage the implementation and maintenance of quality assurance systems and activities, ensuring compliance to site and corporate policies, applicable regulations and providing strategic and technical input for standard and best practices for regulatory compliance.
2. Manage Quality Assurance personnel to ensure all aspects of manufacturing operations and quality control are fully supported to meet compliance and business expectations.
3. Manage the generation, review, and archival of documents and records used to support Good Manufacturing Practice.
4. Manage CAPA, complaint, investigation, internal audit, and deviation systems, ensuring timely resolution of these records to meet compliance and business expectations.
5. Manage quality system training program, ensuring comprehension and compliance of procedures throughout cross functional areas at the site.
6. Manage vendor quality management program including vendor approval, complaints, and audits.
7. Use critical thinking skills to bring solutions to quality and technical topics such as investigations, root cause analysis, and risk management tools.
8. Support site and corporate continuous improvement efforts for the quality system and processes.
9. Support validation efforts for processes, methods, and equipment.
10. Write, revise review and approve standard operating procedures.
11. Develop and generate quality system metrics for tracking and trending purposes and recommend actions as appropriate.
12. Be able to make data driven and highly technical decisions that support compliance and site quality policy.
14. Act as mentor for Quality Assurance by setting a clear vision of goals and objectives that are aligned with site and corporate initiatives and following through on them by providing guidance, support, and feedback on team member performance.
15. Participate in FDA inspections
16. May perform additional duties as required.
Essential Job Requirements:
1. Bachelor’s degree in a scientific discipline or equivalent.
2. At least 7-10 years of managing a quality assurance function within a cGMP environment with demonstrated experience in overseeing product Quality from clinical supply to commercial manufacturing. Biologics experience is required.
3. Functional understanding and experience with aseptic processing and the technologies used to support it including sterility assurance, environmental monitoring, contamination control and facility design and layout (classification schemes).
4. Excellent oral and written communication skills.
5. Excellent organization and project management skills
6. Strong critical thinking skills.
7. Working knowledge of cGMPs and regulations including experience hosting or facilitating regulatory inspections (PAI and routine).
8. Proficiency with Microsoft Word, Powerpoint, and Excel. Experience with an eQMS solution a plus.
9. Ability to travel (supplier audits) 5%.