The Sr. Manager/Associate Director of Quality Operations is critical in providing Quality oversight of the cell and gene therapy manufacturing facility and ultimately ensuring successful execution and maintenance of the established process and procedures. This role supports Manufacturing, Laboratory and Warehouse Operations and is required to be onsite in Alameda, CA.
Responsibilities:
Provide leadership for Quality oversight for the cGMP operations of the Alameda facility, including support for the establishment of Manufacturing, Laboratory and Warehouse operations
Execute and improve process and procedures for batch record review
Support risk management activities and approve risk management reports
Serve as subject matter expert and support communications with customers on Quality topics and project plans.
Serve as a subject matter expert for Health Authority inspections and internal audits
Establish and execute material and product disposition activities, in compliance with US and EU requirements
Support new product introduction activities, including Quality oversight of tech transfer
Collaborate with Quality Validation to support oversight of facilities and engineering related processes for equipment, facilities and utilities, post qualification.
Quality oversight activities for deviations, CAPAs, change controls, and laboratory investigations.
Managing and assessment vendor-initiated changes impacting the site
Manage performance and development of direct reports
Qualifications:
BA or BS in life science degree
8+ years of experience in the pharmaceutical or biotechnology industry in Quality Assurance or Quality Systems or equivalent combination of education and work experience
Demonstrated experience in Quality Operations functions within a GMP facility of cell/gene therapy products or biologics in both clinical and/or commercial settings
Previous experience in Quality Operations, in start up or operational setting
Ability to effectively prioritize and deliver high-quality results on tight timelines.
Extensive knowledge of cGMPs
Excellent written, verbal communication and presentation skills
Resilient leader and willing to collaborate across cross functional teams