Director of Bulk Operations

Vor 3 Tagen

ValdeTravers District, Schweiz WuXi AppTec Vollzeit

Job Summary:


As a key member of the WuXi AppTec team, we are seeking an experienced Bulk Operations Manager to lead our manufacturing operations and ensure the highest standards of quality and health & safety.



Key Responsibilities:

  • Lead the daily management of the Bulk team, including planning, communication, team organization, and control to ensure timely delivery of targets.
  • Develop and manage the Bulk Operations team for all activities in scope, including bulk manufacturing, planning, team organization, control, monitoring of defined targets, and cleaning.
  • Define the mid-term strategy for the department, including activities, projects, and resource planning, with a focus on gap assessment and succession planning.
  • Lead corrective actions and improvement initiatives within the Bulk Operations Department, ensuring compliance with GMP regulations.
  • Manage the execution and tracking of all activities, ensuring KPIs are defined and met as per targets.
  • Lead site-related cross-functional projects and act as a Subject Matter Expert (SME) in cross-functional/multi-site projects.
  • Propose, sponsor, and manage investment, improvement, and evolution projects, acting as SME in cross-functional/multi-site projects.
  • Support the manufacturing head in establishing and following the bulk budget.
  • Ensure traceability and compliance of operations carried out by the team.
  • Conduct investigations into Bulk failures, develop and implement remediation plans.
  • Ensure Bulk representation during health authorities' audits (e.g., FDA, Swissmedic, EMEA) and internal audits.
  • Define, control, and ensure traceability of operations carried out, including Bulk batch records.
  • Draft Standard Operating Procedures (SOPs) and working procedures linked to the area of responsibility.
  • Conform to the directives and instructions defined in the pharmaceutical site quality system and EHS.
  • Apply risk management techniques and participate in risk assessment/analysis groups linked to packaging processes.


Qualifications:

  • Master's degree
  • More than 5 years of experience in the pharmaceutical industry, preferably in bulk GMP activities
  • More than 3 years of management experience in GMP activities and people


Requirements:

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


WuXi AppTec is an equal opportunities employer and welcomes applications from all qualified candidates.

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