Overview
This position is a leadership role responsible for the direct management of individual contributors and/or supervisors and/or managers.
This position serves as a safeguard and role model for WuXi values and competencies.
Job Summary:
Lead bulk operations to ensure packaging goods are produced according to supply needs and meet the highest standards of quality and health & safety.
This key player in product manufacturing works closely with QA, QC, production, and logistic departments.
Responsibilities
* Manage daily Bulk team operations (planning, communication, organization, control, and target checking to ensure timely delivery).
* Oversee and develop the Bulk Operations team for all activities within scope (bulk manufacturing, planning, communication, organization, control, monitoring of targets) and cleaning (planning, manufacturing clean rooms, cleaning execution, and associated documentation).
* Develop mid-term strategy for the department regarding activities/projects and resource planning (gap-assessment, succession plans).
* Implement corrective actions and improvement initiatives within the Bulk Operations Department.
* Ensure execution and tracking of all activities in compliance with GMP, meeting defined KPIs for Bulk Operations activities.
* Manage bulk operations planning compared to logistic 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).
* Suggest, sponsor, and manage investment, improvement, and evolution projects, acting as SME in cross-functional/multi-site projects.
* Support manufacturing head in establishing and following the bulk budget.
* Evaluate and ensure traceability and compliance of operations carried out by the team.
* Ensure training conformity of the Bulk team for primary/secondary and manual activities.
* Investigate Bulk failures, develop, and implement remediation plans.
* Represent Bulk during health authorities audits (FDA, Swiss medic, EMEA) and internal audits.
* Define and control pre-established documentation to ensure traceability of operations (Bulk batch record).
* Draft Standard Operating Procedures and working procedures related to the area of responsibility.
* Adhere to pharmaceutical site quality system and EHS directives and instructions.
* Apply risk management techniques and participate in risk assessment/analysis groups related to packaging processes.
Qualifications
Experience/Education
* Master's degree in Science
* More than 5 years of experience in the pharmaceutical industry, preferably in bulk GMP activities
* At least 3 years of management experience in GMP activities and people
Knowledge/Skills/Abilities
* Strong working knowledge to ensure Bulk activities comply with applicable regulations (cGMP, FDA)
* Fluent in English and French
* Organized and rigorous, able to provide leadership and coaching to the Bulk team for trust and personal accountability
* Effective communication skills at all levels of the organization
* Able to take decisions
* Technical skills to apply LEAN approaches
* Autonomous and willing to work on the ground
* Quality and integrity oriented
* High level of computer literacy (MS Office, Excel)