Manufacturing Service Manager

4 days ago


Shanghai, Shanghai, China Roche Full time

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die Position

1. Primary Purpose of Job (Job Summary)

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 Logistic Manager leads and manages critical operations within the Manufacturing Department of our new aseptic facility. This role will focus on maintaining cleanliness in classified areas, overseeing the full lifecycle management of cleanroom garments, and handling the cleaning and sterilization of components required for aseptic filling equipment. Ensuring all activities in Logistic are executed safely and timely in full compliance and consistency with GMP/ SHE requirements and Roche's corporate principles, quality policies and standards.

  • Enable and empower your team to achieve our vision by leveraging creative leadership competencies and exemplifying the Leadership Commitments.
  • Play a critical part in strategic project realization including facility design, qualification and manufacturing readiness and start up.
  • The role is key interface with the QA, F&E, MSAT, QC to ensure all activities in Logistic smooth and efficient running and drive consistency between the different teams with the department.

2. Principle Roles & Responsibilities / Accountabilities

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:

  • Participate in new facility design and construction, including but not limited to process design, equipment selection, URS review, FAT, SAT, IOPQ, APS etc. to contribute to project delivery.
  • As a key role to maintaining an effective operation system in alignment with the Roche's standards, including manufacturing system, CCS strategy, people training and qualification system.
  • Responsible for CCS strategy implementation in Logistic function ensure a sustaining sterility assurance program setting up.
  • Assist manufacturing head to setup team and people hiring schedule to build a competitive team that meets the project and production ramp up plan.
  • Ensure team's competencies in performing the following tasks: e.g. facility cleaning, gowning, parts washing and sterilization.
  • Coordinate with cross-functional teams to ensure all systems, processes, and resources are ready for operation.
  • Perform other duties as assigned.

Routine Operation:

  • High level readiness in place to support manufacturing, ensure routine operation in compliance with Roche's GMP/SHE and regulation requirements.
  • Lead the full lifecycle management of cleanroom garments, including procurement, qualification, distribution, laundering, and replacement to enable consistent supply and adherence to cleanliness protocols.
  • Oversee garment lifecycle processes manage component cleaning and sterilization activities, maintaining equipment qualification,ensuring schedules are met and standards upheld.
  • Maintain accurate, GMP-compliant documentation and processes to support inspections and audits.
  • Identify, assess, and mitigate risks within logistics operations to maintain process integrity.
  • Lead process optimization initiatives to improve efficiency, quality, and performance.
  • Involve in the deviation investigation, including appropriate escalation where needed to ensure closure of deviation within the set timeline.
  • Raise change control and provide assessment.
  • Perform other duties as assigned.

3. 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, with proven expertise in facility cleaning, garment management, and sterilization processes 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.
  • Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry.
  • 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.

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.


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