Associate Director Process Excellence, Launch Operations

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director Process Excellence, Launch Operations leads the Process Excellence team, ensuring robust manufacturing processes, compliance, innovation and continuous improvement within P3. This role leads a multi-disciplinary team to drive and ensure technical readiness for new product introductions, lifecycle management, and process optimization while maintaining and owning GMP standards and processes and supporting regulatory requirements; and ensure late-stage development priorities and timely technical transfers, as well as Phase 3 clinical and future commercial production. Duties/Responsibilities Leadership & Strategy

• Lead a team of Technical and Compliance Process Excellence SMEs.
• This role sits within the P3 Leadership Team and is responsible for influencing direction and ensuring execution of site objectives, vision and strategy.
• Define and implement the Process Excellence roadmap for P3 aligned with site and global objectives.
• Act as a servant leader to develop his/her team promoting a coaching and feedback culture
• Create an environment that fosters accountability, innovation, learning, and knowledge sharing.
• Build robust technical and compliance capabilities in line with PU requirements.

Technical Readiness & Process Improvements

• Contribute to timely and efficient manufacturing operations by ensuring technical process ownership and expertise within the PU.
• Ensure support for technical gap assessments, and technical transfer plans.
• Acts as a key contributor to process technology transfer activities.
• Oversee execution of batch record authoring, and MES creation.
• Ensure execution of protocols, reports, and deviation support for new equipment and processes.
• Drive lifecycle management initiatives, including KPI monitoring, process robustness reviews, and continuous improvement projects.
• Support data analysis and identification of potential process shifts/trends and escalate as necessary.
• Support PU MS&T in providing timely updates to management on status of process performance.
• Support regulatory filings.
• PU equipment expert.
• Lead site-related cross-functional projects and act as SME in cross-functional/multi-site projects.

Project Owner of CAPEX Investment Projects

• Accountable for execution and delivery of expected outcomes.
• Own operational readiness project workstream.
• Provide decision support and guidance to the entire project team.
• Act as the communication link between Project Manager and sponsor.

Compliance

• Own and manage GMP documentation, CAPAs, Change Controls, deviations, risk assessments and related KPIs.
• Act as first-line point of contact for and contribute to audits, inspections, and regulatory requests, ensuring inspection readiness.
• Maintain their processes at inspection readiness level and provide the necessary support in any internal or external audit and authorities inspections.
• Work with Scheduling, Manufacturing, MS&T and QA to ensure that batches are released on time through the closure of robust investigations and impact/risk assessments.

Cross-functional Collaboration

• Partner with P3 Manufacturing, MS&T, QA, PM and EHS to ensure seamless execution of technical and compliance activities.
• Ensure close collaboration with members of P1 leadership team for alignment, decision making, and best practice sharing.
• Lead the development of training (as immediate response to unexpected events, for technical document execution, and new products/processes) and ensure adequate document/curriculums at all-time for P3 Manufacturing and Process Excellence Teams.
• Provides the necessary training and support to new associates joining the Process Excellence Team.

EHS Responsibilities

• Promote and ensure adherence to Environmental, Health, and Safety standards in all activities.
• Accountable for EHS CAPA (including management and tracking), EHS SPOC, and for driving safety & ergonomic improvements in the PU in collaboration with the PU3 EHS.

Innovation & Digital

• Lead or oversee digital, AI, and innovation activities, projects and initiatives for the PU.
• Identifies and promotes opportunities for process, operational, and quality improvements in conjunction with PU LT

Qualifications

• Advanced degrees in Pharmaceutical Sciences, Engineering, or related field are required.
• Minimum 8 years of relevant experience in pharmaceutical manufacturing, with strong expertise in process engineering and compliance.
• 5+ years of team leadership experience in pharmaceutical industry is required, ideally leading process excellence, process expert or MS&T teams.
• Fluent French and English are required.
• Proven leadership in technical readiness and continuous improvement projects.
• Knowledge of regulatory requirements, and risk management tools.
• Strong working knowledge of GMP and FDA, Eudralex, PICS, and GAMP regulatory requirements, and previous GxP experience is required.
• Excellent communication, presentation, and collaboration skills.
• Occasional business-related travel is required.
• Demonstrated ability to communicate effectively at all levels of the organization.
• Excellent skills to influence stakeholders across functions and hierarchical levels.
• Experience in Lean Manufacturing/Six Sigma.
• Exceptional problem-solving ability.
• Ability to effectively utilize Microsoft Office Suite.
• Experienced at presenting during regulatory audits (FDA and SwissMedic).
• CAPEX investment project experience.