Sr Director, Quality Assurance
About The Position
The Sr. Director of Quality has the overall responsibility for Global Quality Assurance (QA) operations at both the RTP and OSD sites. Additionally, the Sr. Director role has a heavily strategic component, being responsible for the relationships with the senior management of key partner and joint venture organizations (such as EISAI, Samsung, and J&J) pertaining to site operations. This function has the responsibility to ensure the requirements of all Quality System Regulations are effectively established and maintained to provide PO&T with scalable Quality activities within all business areas. The Sr. Director is accountable for the establishment and maintenance of recipe-based modernization of Quality systems supporting manufacturing. 1) Disposition, release and distribution of commercial and clinical drug substance manufacturing from the existing RTP 15K and 2K facilities 2) Oversight of small molecule manufacturing at OSD, including both Biogen clinical and commercial operations as well as clinical and commercial operations contracted to the site 3) Partners with site leadership to establish strategy for Biogen campuses locations at 5000 and 900 Davis Drive. Inherent in 1)-3) this also includes but is not limited to a) QA oversight of QC, manufacturing and engineering activities at both sites b) QC activities for all OSD operations c) Quality oversight of incoming production materials d) QA oversight of QC activities supporting 1)-3) as well as DP analyses and small molecule analytical program. e) Quality Engineering support of site expansion and site operations
Requirements
- 8 – 12 years in: - Pharmaceutical Quality Management - Quality Assurance and Quality Control Systems - Validation - CMC registration
- University degree, preferable Ph. D in a field of Science
Responsibilities
- Overall responsibility for Global Quality Assurance (QA) operations at both the RTP and OSD sites.
- Responsible for the relationships with the senior management of key partner and joint venture organizations (such as EISAI, Samsung, and J&J) pertaining to site operations.
- Ensure the requirements of all Quality System Regulations are effectively established and maintained to provide PO&T with scalable Quality activities within all business areas.
- Accountable for the establishment and maintenance of recipe-based modernization of Quality systems supporting manufacturing.
- Disposition, release and distribution of commercial and clinical drug substance manufacturing from the existing RTP 15K and 2K facilities
- Oversight of small molecule manufacturing at OSD, including both Biogen clinical and commercial operations as well as clinical and commercial operations contracted to the site
- Partners with site leadership to establish strategy for Biogen campuses locations at 5000 and 900 Davis Drive.
- QA oversight of QC, manufacturing and engineering activities at both sites
- QC activities for all OSD operations
- Quality oversight of incoming production materials
- QA oversight of QC activities supporting 1)-3) as well as DP analyses and small molecule analytical program.
- Quality Engineering support of site expansion and site operations
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
