The Role:

Abata is looking for a talented Quality Assurance lead to oversee our external GMP manufacturing activities and to support our internal GxP activities and QMS system.  This position will be integral in our quest to provide innovative and transformative therapies to patients.  Some of the key components of this role include oversight and collaboration with our external manufacturing organization, disposition of drug product, quality event management, internal QMS management, and cross-functional QA representation on sub-functional teams.

Major Responsibilities:

• Independently represents Quality Assurance in day-to-day interactions with contract manufacturer and internal cross-functional teams
• Reviews and approves master batch records, executed batch records, and test procedures and records.
• Dispositions drug product and supports Clinical Trial Material shipment.
• Supports investigations regarding Good Manufacturing Practice (GMP) related quality events.
• Reviews and approves deviations, CAPA, investigations, and out-of-specification investigations.
• Supports change management at contract manufacturer, and maintains/supports internal change management.
• Supports the establishment and oversight of internal translational laboratory and testing.
• Reviews and approves internal protocols and reports.
• Works cross-functionally across the organization.
• Participates in external auditing.
• Supports the establishment of an internal auditing program
• Administers the QMS system and training program.
• Effectively represents Quality Assurance, both internally and externally.

Requirements and Qualifications:

• Bachelor’s degree or higher in Biology, Chemistry, Microbiology, Life Sciences, or an equivalent scientific discipline
• Experience in quality or regulatory compliance within pharmaceutical, biologics, or cell therapy manufacturing (cell therapy experience is desired)
• 5+ years Good Manufacturing Practice (GMP) experience
• Travel up to 30% (mostly local)
• Not a remote position, flexible work schedule