Associate Director, Drug Product External Manufacturing Quality Assurance

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The Associate Director, Drug Product External Manufacturing QA provides Quality oversight to Contract Manufacturing Organizations (CMOs) production and disposition. This role will partner cross functionally with Global Product Quality (GPQ), External Manufacturing (ExM), Manufacturing Science & Technology (MS&T/CTTO), Analytical Science & Technology (AS&T) and Supply Chain (SC) teams to provide QA oversight of CMO(s) including Deviations, CAPAs, Change Controls, Batch Record Review, Lot disposition to support the clinical and commercial release of Drug Product. This role will also develop and manage the collaboration and governance relationship with CMOs during technology transfer and routine operations and ensure CMO(s) remains compliant to regulatory requirement and BMS procedures.

Shift Available:

• Monday - Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.

Responsibilities:

• Provide QA oversight during CMO on-boarding process including Technology Transfer studies, data auditing, review/approval of protocol/reports, and inspection readiness activities such as GMP assessment, mock/regulatory PLIs, and system remediations.  

• Responsible for quality approval on CMO manufacturing batch record, investigations, CAPA, change control records, and disposition 

• Participate in the vendor Health Authority inspections and provide support as the BMS representative 

• Collaborate with Quality Systems and ensure CMO’s timely implementation of corrective actions resulted from BMS’s audits  

• Establish Quality Agreement with CMOs and ensure compliance, and oversee trending of key quality, product and GMP metrics 

• Provide guidance and governance to cross functional internal and CMO teams on quality compliance and GMP requirements for CMO manufacturing  

• Participate in Material Review Board meetings and evaluate recommendations made by the board  

• Ensure the Annual Product Review reflect the operations performed by CMOs, provide the appropriate level of detail and required trend analysis 

• Identify gaps at the assigned CMOs and provide pragmatic solutions aligned with business needs 

• Champion a culture of agility and continuous improvement 

• Mentor and enable development of direct and indirect reports 

• Other Quality responsibilities may be assigned  

Knowledge & Skills:  

• Expertise in GMP, Quality, and risk management 

• Ability to interpret problems, scientific based decision making and effectively prepare communication in a productive manner to management and cross functional teams with clarity, brevity, and accuracy 

• Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles 

• Must be able to recognize patterns and tren