Process Team Lead

Biopharma Careers; Pendik; On-site; TRY 200,000 - 360,000; Full time

Job summary

Biopharma Careers in Turkey is seeking a Process Team Lead to oversee daily manufacturing operations within the Manufacturing Unit, fostering a culture of empowerment, accountability, and continuous improvement.

You will ensure high-quality products in line with GMP, HSE, and regulatory standards while driving operational efficiency, resource planning, and team development across production lines.

Qualifications

• Bachelor's Degree in Pharmacy, Chemical Engineering, Chemistry, Pharmaceutical Technology, Life Sciences, or a related field.
• 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.
• Strong knowledge of GMP regulations and pharmaceutical manufacturing processes.
• 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.

Responsibilities

• Provide visible leadership on the shop floor through regular presence and operational support.
• Review and manage production schedules and resource allocation.
• Support CAPAs and actions related to operational performance indicators.
• Lead incident reporting, investigations, root cause analyses, and corrective actions.
• Promote safety, quality, and regulatory compliance across the manufacturing unit.
• Develop, coach, and mentor team members and shift leaders.

Education

Bachelor's Degree in Pharmacy, Chemical Engineering, Chemistry, Pharmaceutical Technology, Life Sciences, or a related field

Job description

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.

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.