Manufacturing Unit Leader- Pharma

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 delivering business performance targets. This role oversees cross-functional teams to ensure safe, high-quality, and efficient production, aligned with BD’s transformation, compliance remediation, and continuous improvement initiatives.

As a Pharma Manufacturing Leader, this position operates in a highly controlled environment involving chemical and biological products, where risk is directly associated with dose accuracy, product potency, and contamination control. The role places a critical emphasis on robust process control, sterility assurance, and reproducibility to guarantee consistent product quality and patient safety.

Job Responsibilities:

Operational Leadership

• 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 (changes may require re-validation, requalification, or regulatory approval).

• 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

• Gowning, airlocks, and facility compliance standards

• Recognize that facilities and utilities are integral to process validation and product quality.

Compliance & Quality

• Ensure full compliance with FDA regulations, GMP standards, BD Quality Systems, and internal procedures, maintaining an always 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.

People Leadership & Engagement

• 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 and deviation reduction

• Accepting structured, deliberate decision-making processes

• Maintaining focus on contamination control, batch release, and inspection readiness.

• Promote BD Values, a strong Speak Up culture, and an inclusive, respectful work environment.

Operational Excellence & Continuous Improvement

• 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, with particular focus on deviation reduction, batch release efficiency, and right-first-time execution.

• Support Factory Blueprint implementation and sustain standard work practices across the unit

Safety & EHS

• 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.

Cross-functional Collaboration

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

• Support new product introductions (NPI), validation activities, and process transfers.

• Align resources to meet production and business priorities.

BD Excellence, TMS, and Continuous Improvement

• Lead the TMS cycle and set the 24‑hour direction for the Manufacturing Unit.

• Sustain BD Excellence through Daily Tier Meetings (DTM), Clean/Inspect/Lubricate (CIL/CL) standards, and loss elimination practices.

• Drive short- and long-term improvements aligned with SQDCP (Safety, Quality, Delivery, Cost, People) objectives.

Other Responsibilities

• Perform additional duties as required to support the needs of the business and site operations.

Education and Experience:

• Bachelor’s Degree in Engineering, Life Sciences, Manufacturing, or related field required. Master’s Degree preferred

• 5+ years of manufacturing experience in Pharma is required.

• Minimum 3–5 years in people leadership roles

• Strong experience with FDA regulations, GMP compliance, and audit management

• Proven track record in continuous improvement (Lean, Six Sigma preferred)

• Flexibility to support multiple shifts and business needs

• Ability to work in a fast-paced, highly regulated manufacturing environment.

Knowledge and Skills:

• Strong knowledge of pharmaceutical/medical device manufacturing processes

• Experience with deviation management, CAPA, and quality systems

• Familiar with ERP systems (e.g., SAP, Workday) and production planning tools

• Data-driven mindset with ability to analyze and act on performance metrics

• Strategic thinking and execution

• Strong decision-making and problem-solving skills

• Effective communication across all organizational levels

• Change management and transformation leadership

• Collaboration and influence across cross-functional teams

Work Environment:

On‑site role in a clean, highly regulated, high‑volume medical device/pharma manufacturing facility. Requires interaction with Quality, Production, EHS, Engineering, and Facilities teams.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare.