Site Lead Operational Service (m/w/x)

Responsibilities

• Operational Services Leadership
• Provide end‑to‑end leadership for the Operational Support / Services function, ensuring reliable, responsive, and scalable support to manufacturing operations
• Integrate priorities across production, quality, engineering, supply chain, and EHS to enable stable and predictable operations
• Serve as a core member of the site leadership team, shaping operational direction and priorities
• Compliance & Inspection Readiness
• Own site‑level operational quality systems, including deviations, investigations, CAPAs, change control, data trending and analysis, MES, batch record review, order lifecycle management, detailed scheduling, SOP lifecyle management and GMP training
• Ensure continuous inspection readiness for global health authorities (e.g., FDA, EMA)
• Translate regulatory expectations into consistent, disciplined execution at the shop‑floor level
• Represent the organization as a senior leader during inspections and audits
• Execution Excellence & Operational Delivery
• Ensure timely, high‑quality execution of: Investigations and CAPAs
• GMP training programs, SOP changes and compliance activities
• Detailed scheduling & Batch Record Review
• Continuous improvement and OpEx initiatives
• Operational readiness and support programs
• Establish strong prioritization, governance, and performance management processes
• Continuous Improvement & Operational Excellence
• Lead deployment of Lean, Six Sigma, and structured problem‑solving methodologies
• Define and execute a site‑level continuous improvement (CI) strategy aligned to network priorities
• Drive process simplification, standard work, and performance transparency
• Embed a culture of continuous improvement and operational discipline
• Financial Ownership & Value Realization
• Own financial governance for CI initiatives, operational projects, and cost improvement programs
• Ensure clear identification, tracking, and realization of OpEx savings, productivity gains, and quality improvements
• Partner closely with Finance to ensure rigorous benefit validation and reporting
• Talent, Leadership & Organizational Capability
• Lead and develop a high‑performing, manager‑led organization
• Build succession pipelines and future leadership capability
• Coach leaders to operate with enterprise mindset, accountability, and cross‑functional effectiveness
• Embed quality mindset, CI discipline, and execution excellence across the organization
• Stakeholder Alignment & Network Integration
• Align site Operational Services priorities with network and enterprise manufacturing strategy
• Provide clear visibility to leadership on performance, risks, and improvement progress
• Drive cross‑site learning, standardization, and best‑practice adoption
• Act as a connector between site execution and global operations strategy
• Completes any other duties/responsibilities assigned by senior management.
• Education Requirements
• Bachelor's degree in Engineering, Science, or related field.
• Advanced degree (MS, MBA, or equivalent) preferred.
• Experience Requirements
• 10+ years of experience in GxP-regulated manufacturing (pharma, biotech, or medical device)
• Demonstrated leadership of multi‑functional or Operational Services organizations
• Strong experience in regulatory inspections and compliance systems
• Proven track record in continuous impro

Benefits

Additional Information

The Senior Director, Site Operational Service Lead is accountable for leading a critical, enterprise ‑ connected Operational Services function that enables safe, compliant, and high ‑ performing manufacturing execution within a complex, regulated biopharmaceutical environment. This role serves as a strategic and operational partner to site leadership, ensuring the effective integration of quality, continuous improvement, training, and operational readiness capabilities to deliver sustained performance outcomes. The position owns end ‑ to ‑ end manufacturing support systems, including deviation and CAPA management, inspection readiness, GMP training, and continuous improvement deployment. It ensures these systems not only meet regulatory expectations but also drive predictable, efficient, and scalable operations aligned to network and enterprise priorities. In addition, the role drives disruptive innovation and simplification across Operational Services by leveraging digitalization, automation, and advanced analytics, including the application of artificial intelligence, to unlock significant efficiency gains and fundamentally improve operational performance. This role is fully accountable for the transformation and step-change improvement of the overall Operationa l Services organization, with a clear mandate to significantly increase efficiency, effective n enss , and value contribution to the business. Operating at a manager ‑ of ‑ managers level, the Senior Director leads multiple teams and functions, translating enterprise strategy into execution, while building the organizational capability required to support current operations and future growth.

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