GMP Service Manager

Manager, Greenfield Facility

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Roche is hiring for a greenfield facility in Shanghai and we are looking for dynamic leaders who can establish operations, collaborate closely with the project team to execute this strategic initiative—including facility design, qualification, manufacturing readiness and start-up—and oversee daily operations to ensure long-term success, whilst also displaying strong people leadership skills to build and grow new teams. This is a Manager position. Strong skill and experience are required to cover two areas: Greenfield project delivery and Routine Operation. The GMP Service Manager is responsible for establishing and managing key systems and processes to support production operations and providing leadership and oversight to all routine operational and administrative activities which occur within the responsibilities i.e. training and personnel qualification, documents control, MES and Aspire operation, coordination of Change/Deviation/CAPA, risk management, coordination of OE.

• Enable and empower your team to achieve our vision by leveraging creative leadership competencies and exemplifying the Leadership Commitments.

• Oversee the implementation of production management systems, coordinate changes and deviations related to quality processes, assist the Production Head in production readiness activities, and lead departmental risk management and Operational Excellence (OE) initiatives.

• The role is key interface with the Quality, F&E, MSAT,MM, site Digital & OE to ensure production smooth and efficient running and drive consistency between the different teams within the department.

Leadership & People Management

• Possesses strong creative leadership competencies and integrates Leadership Commitments into daily practices. Demonstrates the ability to cultivate a forward-thinking outlook, remove barriers, develop people's skills and technical capabilities, and create an environment that empowers individuals to perform at their best.

• Build and retain an inclusive workforce and foster an environment where diversity of thought and perspective are valued.

• Build and maintain strong partnerships with site leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.

• Take the responsibility for department daily SHE management, implement site SHE procedure and program, and achieve site corporate /site SHE KPI. Promote SHE culture and improve employee safety behavior.

• Lead, coach, and guide the organization. Manage performance and development team members to achieve organizational goals and employee personal and professional growth.

• Build a strong pipeline of talent and robust succession plans for key positions.

• Maintain a culture of continuous improvement and model lean leadership principles.

• Maintain a culture of transparent, high performance, empowerment and innovation culture.

Technical

Engineering Project Support and Operation Readiness:

• As a key role to establish and maintain an effective operation system in alignment with Roche's standards, including MES, Aspire, training and qualification system, risk management.

• Setup team and build MFG management system ensure meet the project and production ramp up plan.

• Support the Manufacturing Head in planning and executing all activities required to prepare for full-scale production operations.

• Coordinate with cross-functional teams to ensure all systems, processes, and resources are ready for operation.

Routine Operation:

• High level readiness in place to support manufacturing, ensure routine operation in compliance with Roche's GMP/SHE and regulation requirements.

• Ensure seamless integration of production-related systems (MES, Aspire) with production workflows to facilitate efficient and compliant operations.

• Act as the primary liaison between the production team and the quality team to manage changes, deviations/CAPA, and related quality events. Ensure timely resolution of issues, while maintaining compliance with GMP and regulatory standards.

• Develop and implement risk management strategies, identifying potential risks and designing mitigation plans. Conduct regular reviews to ensure risks are identified, monitored, and controlled effectively.

• Drive the implementation of Operational Excellence (OE) initiatives within the manufacturing department. Foster a culture of continuous improvement, streamlining processes, and enhancing productivity and efficiency.

• Support consumable materials/service introduction and track the status to ensure to meet the manufacturing requirement.

• Control the department document and logbook, including status track, distribution and recycling.

Qualification and Experience

Education/Qualifications:

• Bachelor's Degree in Pharmaceutical Engineering, Biotechnology, Manufacturing field and above.

Job Required Competencies:

• 10 or more years' operation experience in the GMP production environments, including significant experience with MES, SAP or other digital production systems in the pharmaceutical industry, MNC preferred.

• 5 or more years' people management experience.

• Experienced in new facility startup readiness and operation ramp up including qualification and routine maintenance.

• Proficiency in MES,SAP and other production-related systems, with a proven ability to lead system implementations.

• Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry.

• Prior experience in risk management and OE initiatives is highly desirable.

• Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working.

• Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.