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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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