Associate Director - EMES Operational Excellence and Compliance

Associate Director – EMES Operational Excellence and Compliance

Company	Bristol Myers Squibb
Location	Bothell, WA, USA, Princeton, NJ, USA, Edison, NJ, USA, Devens, MA, USA, Dublin, Ireland
Salary	$Not Provided – $Not Provided
Type	Full-Time
Degrees
Experience Level	Senior, Expert or higher

Ten (10) or more years of experience in pharmaceutical quality operations, with at least 6 years’ experience in GMP execution systems.
Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 & S95)
Expertise with 21 CFR Part 11 and GAMP standards for validation of automated systems is required.
Experience with IT oversight of electronic systems for GMP operations is required.
Demonstrated excellence in written and verbal communication.
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
Demonstrated ability to work effectively with US FDA and other regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP, ISO and other applicable standards.
Demonstrated record with driving continuous improvement and fostering a compliant operational excellence culture.
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a leader of team(s) to engage and influence team members in a matrixed environment.
Ability to travel up to 20% domestically and internationally (*when not restricted)

Develop and oversee the execution of overall EMES operation strategies, including tier meeting structure, demand intake and workload management, incident management, crisis management, KPI management, training design, and knowledge management.
Drive continuous improvement by leveraging Agile, Lean, or other methodologies and innovative technologies, including but not limited to Artificial Intelligence.
Act as the point of contact for quality and CSV organizations, overseeing validation and qualification activities for MES solutions.
Lead EMES validation resources to deliver on commitments.
Provide overall IT compliance guidance to the EMES team, including Data Integrity, CSV practices, deviation management, change control, incident management, and investigations.
Define and own the EMES change management strategy, ensuring consistency between EMES and site operations.
Understand the Global MES design and work closely with the development lead and team to ensure that testing and deployment approaches, including SDLC and CSV testing, are aligned with development.
Collaborate with the development team to create standards that support recipe-driven manufacturing execution systems across the manufacturing network for all batch processing activities, from lab to patient.