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