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Manager Bulk Operations Manufacturing, Val-de-Travers
Client:
WuXi AppTec
Location:
Job Category:
Manufacturing
Job Reference:
689707d21c80
Job Views:
4
Posted:
25.04.2025
Expiry Date:
09.06.2025
Job Description:
Overview
This position is a leadership role responsible for the direct management of individual contributors, supervisors, and/or managers. It 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. This position will 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 for all activities in scope (bulk manufacturing, planning communication, team organization, control, monitoring of defined targets) and cleaning (planning, manufacturing clean rooms, cleaning execution, and associated documentation).
* Define the mid-term strategy for the department regarding activities/projects and resource planning (gap-assessment, succession plans).
* Lead corrective actions and improvement initiatives within the Bulk Operations Department.
* Ensure execution and tracking of all activities in compliance with GMP, defining and meeting KPIs for Bulk Operations activities.
* Manage bulk operations planning in relation to logistics requests to ensure timely delivery.
* Lead site-related cross-functional projects and act as SME in cross-functional/multi-site projects (e.g., Leanovation, Technical Transfer 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.
* Ensure training conformity of the Bulk team for primary/secondary and manual activities.
* Conduct investigations into Bulk failures and develop and implement remediation plans.
* Ensure Bulk representation during health authority audits (i.e., FDA, Swiss medic, EMEA...) and internal audits.
* Define and control all pre-established documentation to ensure traceability of operations (Bulk batch record).
* Draft Standard Operating Procedures 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/or 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 (i.e., cGMP, FDA regulation).
* Fluent in French and English.
* Organized and rigorous, able to provide leadership and coaching to the bulk team to maintain an environment of trust and personal accountability.
* 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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