Manufacturing Unit Leader- Pharma

Job Description

The Pharma Manufacturing Unit Leader (MUL) is responsible for leading end-to-end manufacturing operations within the Pharma unit, ensuring strict compliance with regulatory standards (FDA, GMP) while driving operational excellence and achieving business performance targets. The role oversees cross‑functional teams to ensure safe, high‑quality, and efficient production, aligned with BD’s transformation, compliance remediation, and continuous improvement initiatives.

• Lead end‑to‑end daily manufacturing operations for the Pharma unit, ensuring strict adherence to production plans, safety protocols, and quality standards.
• Provide clear and consistent direction to frontline leaders and production teams across all shifts to ensure alignment and execution discipline.
• Drive effective implementation of Tiered Management and Daily Management Systems (TMS) to establish clear priorities and maintain operational control.
• Oversee core pharma operations, including formulation, aseptic processing, and filling activities.
• Maintain daily focus on deviations and batch disposition, environmental monitoring and cleanroom compliance, sterility assurance, and contamination control.
• Operate with a low tolerance for process variation, ensuring consistency and reproducibility.
• Manage changes through a highly structured change control process, recognizing that every change carries potential regulatory and validation impact.
• Ensure strict adherence to batch record review and documentation practices, QC testing and formal release processes.
• Oversee operations within highly controlled environments, including cleanroom classifications (Grades A–D), environmental and contamination controls, and gowning, airlocks, and facility compliance standards.
• Recognize that facilities and utilities are integral to process validation and product quality.

• Ensure full compliance with FDA regulations, GMP standards, BD Quality Systems, and internal procedures, maintaining an audit‑ready environment.
• Lead inspection readiness and actively support regulatory audits (FDA, internal, and external).
• Drive timely and effective resolution of deviations, non‑conformances (NCRs), and audit findings through robust CAPA processes.
• Reinforce a strong quality culture with accountability at all levels, grounded in the principle: “Follow the process exactly and prove every batch meets specification.”
• Maintain focus on critical pharma risks including dose accuracy, potency, and contamination control.

• Lead, coach, and develop supervisors and production teams to build a high‑performing, compliant, and accountable organization.
• Ensure adequate staffing, capability building, and succession planning for business‑critical roles.
• Demonstrate discipline, rigor, and a zero‑tolerance mindset for deviations.
• Foster a culture of strong governance, documentation excellence, and audit readiness.
• Balance operational performance with compliance priorities by driving compliance discipline, deviation reduction, structured decision‑making, and focus on contamination control, batch release, and inspection readiness.
• Promote BD Values, a strong Speak Up culture, and an inclusive, respectful work environment.

• Lead Lean and BD Excellence initiatives, including Kaizen events, process standardization, and waste elimination.
• Deliver productivity improvements and cost targets aligned with the Cost‑to‑Win (CTW) strategy.
• Leverage KPIs and data analytics to drive performance, focusing on deviation reduction, batch release efficiency, and right‑first‑time execution.
• Support Factory Blueprint implementation and sustain standard work practices across the unit.

• Ensure compliance with EHS standards and promote a zero‑incident safety culture.
• Address risks proactively and lead investigations for safety incidents.
• Partner with EHS to drive preventive actions and regulatory compliance.

• Partner with Quality, Engineering, Maintenance, Supply Chain, and HR to ensure seamless and compliant operations.
• Support new product…