Manufacturing Operations Manager

vor 1 Monat

ValdeTravers District, Schweiz WuXi AppTec Vollzeit
Job Summary

This position is a leadership role responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this role will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health & safety are met.

Responsibilities
  1. Manage the daily operations of the Bulk team, including planning, communication, team organization, control, and monitoring of defined targets to ensure timely delivery.
  2. Develop and implement strategies for the Bulk Operations team, including resource planning, gap assessment, and succession planning.
  3. Lead corrective actions and improvement initiatives within the Bulk Operations Department, ensuring compliance with GMP regulations.
  4. Manage the execution and tracking of all activities in compliance with GMP, ensuring KPIs are defined and met as per targets.
  5. Oversee the management of bulk operations planning compared to logistic requests to ensure timely delivery.
  6. Lead site-related cross-functional projects and act as a subject matter expert in cross-functional/multi-site projects.
  7. Propose, sponsor, and manage investment, improvement, and evolution projects, acting as a subject matter expert in cross-functional/multi-site projects.
  8. Support the manufacturing head in establishing and following the bulk budget.
  9. Ensure traceability and compliance of operations carried out by the team.
  10. Ensure training conformity of the Bulk team for primary/secondary and manual activities.
  11. Conduct investigations into Bulk failures, develop, and implement remediation plans.
  12. Ensure Bulk representation during health authorities audits (e.g., FDA, Swiss Medic, EMEA) and internal audits.
  13. Define, control, and maintain all pre-established documentation to ensure traceability of operations carried out (Bulk batch record).
  14. Draft Standard Operating Procedures and working procedures linked to the area of responsibility.
  15. Conform to the directives and instructions defined in the pharmaceutical site quality system and EHS.
  16. Apply risk management techniques and/or participate in risk assessment/analysis groups linked to packaging processes.
Qualifications

Experience/Education

  1. Master's degree in a relevant field.
  2. > 5 years of previous experience in the pharmaceutical industry, ideally in bulk GMP activities.
  3. > 3 years of management experience in GMP activities and people.

Knowledge/Skills/Abilities

  1. Strong working knowledge to ensure Bulk activities compliance with applicable regulations (cGMP, FDA regulations).
  2. Fluent in French and English.
  3. Organized and rigorous, able to provide leadership and coaching to the Bulk team to maintain an environment of trust and personal accountability.
  4. Demonstrated ability to effectively communicate with the team and at all levels of the organization.
  5. Ability to take decisions.
  6. Technical skills to apply LEAN approaches.
  7. Autonomous and aptitude to work on the ground.
  8. Quality and integrity oriented.
  9. High level of computer literacy (MS Office, Excel).

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