Manager Bulk Operations Manufacturing

Vor 3 Tagen

ValdeTravers, Schweiz TN Switzerland Vollzeit

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Manager Bulk Operations Manufacturing, Val-de-Travers

Client: WuXi AppTec

Location:

Job Category: Manufacturing

Job Reference: 689707d21c80

Job Views: 9

Posted: 21.01.2025

Expiry Date: 07.03.2025

Job Description:

Overview

This position is a leadership role responsible for the direct management of individual contributors, supervisors, and/or managers. This position serves as a safeguard and role model for the WuXi values and competencies.

Job Summary:

Lead the bulk operations and ensure that packaging goods are produced according to supply needs and the highest standards of quality and health & safety. As a key player in product manufacturing, this position will also work closely with QA, QC, production, and logistics departments.

Responsibilities

  • In charge of the daily management of the Bulk team including planning communication, team organization, control, and monitoring of defined targets to ensure timely delivery.
  • Manage and develop the Bulk Operations team across all activities (bulk manufacturing, planning communication, team organization, control, monitoring of defined targets) and cleaning.
  • Define the mid-term strategy for the department regarding activities/projects and resource planning.
  • Lead corrective actions and improvement initiatives within the Bulk Operations Department.
  • Ensure compliance with GMP in the execution and tracking of all activities, and that KPIs are defined and met.
  • Manage bulk operations planning in accordance with logistic requests to ensure timely delivery.
  • Lead site-related cross-functional projects and act as SME in cross-functional/multi-site projects.
  • Propose, sponsor, and manage investment, improvement, and evolution projects.
  • Support the manufacturing head in establishing and following the bulk budget.
  • Ensure traceability and compliance of operations carried out by the team.
  • Ensure training conformity of the Bulk team for primary/secondary and manual activities.
  • Conduct investigations into Bulk failures and develop remediation plans.
  • Ensure Bulk representation during health authority audits and internal audits.
  • Define and control all pre-established documentation to ensure traceability of operations.
  • Draft Standard Operating Procedures and working procedures linked to the area of responsibility.
  • Conform to 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 the packaging process.

Qualifications

Experience / Education

  • > 5 years of previous experience in the pharmaceutical industry, ideally in bulk GMP activities.
  • > 3 years of management experience in GMP activities and people.

Knowledge / Skills / Abilities:

  • 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.
  • Demonstrated ability to effectively communicate with the team and all levels of the organization.
  • Ability to make decisions.
  • Technical skills to apply LEAN approaches.
  • Autonomous with an aptitude to work on the ground.
  • Quality and integrity oriented.
  • High level of computer literacy (MS Office, Excel).
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