Job Description Summary Job Purpose The Process Team Lead is responsible for overseeing daily manufacturing operations within the Manufacturing Unit, fostering a culture of empowerment, accountability, and continuous improvement. The role ensures the delivery of high-quality products in compliance with GMP, HSE, and Novartis standards while maximizing operational efficiency, productivity, and team performance.
Job Description Major Accountabilities Manufacturing Operations & Shop Floor Leadership
• Provide visible leadership on the shop floor through regular presence, walkthroughs, and operational support.
• Ensure adequate resource planning and allocation based on production workload and business priorities.
• Review and manage production schedules within the operational horizon, considering risks, constraints, and opportunities.
• Ensure continuity of production flow through effective coordination of personnel, materials, consumables, equipment, documentation, and supporting services.
• Set operational priorities and adjust plans when unforeseen events occur.
• Optimize the utilization of human and technical resources to meet safety, quality, delivery, and cost objectives.
• Monitor and drive implementation of CAPAs and actions related to operational performance indicators.
• Own shop floor service support activities and management of external workforce supporting cleaning and material handling operations.
• Support technical batch release activities, including batch record review, SOP maintenance, and process documentation management.
• Lead incident reporting, investigations, root cause analyses, and implementation of corrective and preventive actions.
• Demonstrate ownership of manufacturing processes and products, ensuring sustainable operational performance.
Leadership & People Development
• Act as a role model for Novartis Values & Behaviors and promote a culture of trust, collaboration, accountability, and inclusion.
• Translate strategic objectives into clear team goals, priorities, and action plans.
• Build, engage, and motivate high-performing teams that consistently deliver business results.
• Ensure associates are appropriately trained and qualified before performing GMP activities independently.
• Monitor training compliance and competency development of team members.
• Provide coaching, feedback, and performance management support to direct reports and Shift Leaders.
• Facilitate effective decision-making and problem-solving within the team.
• Promote cross-functional collaboration and knowledge sharing across manufacturing teams.
• Support talent development, succession planning, and employee engagement initiatives.
Quality, Compliance & HSE
• Ensure full compliance with GMP, HSE, Novartis Quality Management Systems, and applicable regulatory requirements.
• Maintain inspection readiness and support successful internal and external audits and regulatory inspections.
• Promote a strong safety and quality culture through leadership, accountability, and continuous awareness.
• Ensure implementation and effectiveness of Business Continuity Plans within the area of responsibility.
• Act as the owner of quality and compliance practices defined within the Novartis Manufacturing Manual.
• Drive proactive identification, reporting, and resolution of quality and safety risks.
Continuous Improvement & Operational Excellence
• Champion Operational Excellence through Lean Leadership, Visual Management, Tiered Accountability, Leader Standard Work, and Gemba practices.
• Lead improvement initiatives including TPM, process optimization, technology transfer, digitalization, and productivity improvement projects.
• Drive improvements in Overall Asset Effectiveness (OAE), yield, cycle time, and operational performance metrics.
• Facilitate Root Cause Investigations (RCIs), Kaizens, and problem-solving workshops to eliminate losses and improve performance.
• Utilize data analytics, visualization, and performance monitoring to identify improvement opportunities.
• Ensure sustainability of implemented improvements and achievement of targeted business benefits.
• Contribute actively to site Continuous Improvement strategy and project prioritization activities.
Key Performance Indicators People
• Employee engagement and satisfaction
• Training compliance and qualification status
• Talent development and succession readiness
• Retention and attraction of key talent
Supply & Delivery
• Production volume achievement
• Schedule adherence
• Launch and commercialization performance
• Supply Excellence KPIs
Quality & Compliance
• Batch success rate
• Right-First-Time performance
• Audit and inspection outcomes
• Reduction of human error-related deviations
• Batch documentation quality
Safety
• Lost Time Injury (LTI) rate
• Safety observation and action completion performance
Cost & Productivity
• Budget adherence
• Headcount management
• Cost of non-quality reduction
• Yield and OAE improvements
Continuous Improvement
• Delivery of Operational Excellence projects
• Financial benefits generated through improvement initiatives
• Sustainability of implemented actions
Essential Requirements Education
• Bachelor's Degree in Pharmacy, Chemical Engineering, Chemistry, Pharmaceutical Technology, Life Sciences, or a related field.
Experience
• Minimum 5 years of experience in the pharmaceutical or life sciences industry within a GMP-regulated environment.
• Minimum 2 years of people leadership or supervisory experience is preferred.
• Experience in commercial manufacturing operations is highly desirable.
Technical & Functional Skills
• Strong knowledge of GMP regulations and pharmaceutical manufacturing processes.
• Good understanding of Quality Systems and Health Authority requirements.
• Experience with manufacturing systems (MES, SAP, or equivalent).
• Knowledge of Lean Management and Operational Excellence methodologies.
• Experience in process improvement, problem solving, and root cause investigation.
Leadership Competencies
• Strong leadership and people development capabilities.
• Effective communication, influencing, and stakeholder management skills.
• Proven ability to lead change and drive organizational performance.
• Strong analytical and problem-solving mindset.
• Ability to work effectively under pressure in a fast-paced manufacturing environment.
Languages
• Advanced English proficiency.
• Fluent Turkish.
Skills Desired Data Analytics