This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers.

This position is 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 as per the highest standards of quality and health & safety.

As a key player of the product manufacturing, this position will also be working closely with QA, QC, production, and logistic departments.

• In charge of the daily management of the Bulk team (planning communication, team organization, control, checking of the defined targets in order to ensure delivery on time).
• Managing and developing the Bulk Operations team for all activities in scope (bulk manufacturing, planning communication, team organization, control, monitoring of the defined targets) and cleaning (planning, manufacturing clean rooms, cleaning execution and associated documentation).
• Defining the mid-term strategy for the department with regards to activities/projects and resource planning (gap-assessment, succession plans).
• Leading corrective actions and improving initiatives within the Bulk Operations Department.
• Responsibility for the execution and tracking of all activities in compliance with GMP. Ensuring the KPIs of Bulk Operations activities are defined and met as per targets.
• In charge of the management of the bulk operations planning compared to the logistic request to ensure delivery on time.
• Leading site-related cross-functional projects and acting as SME in cross-functional/multi-site project (Eg: Leanovation, Technical Transfer projects).
• Proposing, sponsoring and managing investment, improvement and evolution projects, acting as SME in cross functional/multi-site project.
• Support manufacturing head to establish and follow the bulk budget
• Ensure traceability and compliance of operations carried out by the team.
• Ensure training conformity of Bulk team for primary/secondary and manual activities.
• Conduct investigations into Bulk failures, develop and implement remediation plan.
• Ensure Bulk representation during health authorities audit (i.e. FDA, Swiss medic, EMEA...), and internal audit.
• Define, Control, all pre-establish documentation to ensure traceability of operations carried out (Bulk batch record).
• Drafting of Standard Operating Procedure, and also working procedure 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 to risk assessment/analysis group linked to packaging process.

Experience / Education   

• Master Science degree
• >5 years of previous experience in pharmaceutical industry, ideally in bulk GMP activities
• >3 years of management of 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 in order to maintain an environment of trust and personal accountable
• Demonstrated ability to effectively communicate with the team but also at all levels of the organizations
• Ability to take decision
• 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)