West Pharma Program Manager Global Technology Transfers 

United States, Pennsylvania 

994132791

Lead and manage Technology Transfers, that requires extended knowledge and relevant experience, referring to West sites and process capabilities, for the Global Sites as assigned to the timelines and objectives established. Independent work to ensure that all transfer risks are assessed and appropriate mitigation actions defined by TT team and West network experts. Enhancement of Transfer documentation templates and training of NetOp and site resources. Contribute to the TT team success managed by other leads.

• Propose and agree with NetOp QA TT execution strategy and TT scenario
• Works independently to manage technology transfer projects, globally, to the timelines and objectives established:
• TT projects high complexity, within a region
• Low and mid complexity TT projects between regions
• Manage each project encompassing all aspects of the transfer project (quality, items, customers, capacity, product strategy, transport, equipment, regulatory...)
• Work with Global QA NetOp to determine TT strategy and acceptance criteria.
• Lead and execute transfer projects using West Project Management Best Practices.
• Compiling and approval of a Project Charter, opening and closing of a Change Control
• Planning – priority, complexity, schedule, duration, required resources
• Execution – coordinate completion of all TT activities, documentation, production and testing of required batches
• Communication within West and with customers
• Active contribution in the transfer projects, as a member of a TT core team, managed by other transfer Project Managers
• Gathering and analyses of numerous required data (operation, manufacturing, quality) and information for TT Requirements plan.
• Independent preparation and completion of the Technology Transfer Risk Assessment and Risk Mitigation Plan
• Compiling and analyses of test results and providing appropriate recommendations
• Establish the operational parameters, CQA’s and acceptance criteria to be evaluated
• Guide the West resources on managing required PNR and deviation investigation
• Compiling, review and approval of Technology Transfer Equivalence Protocol (document defining documentation, references, test procedures and acceptance criteria
• Compiling, review and approval Technology Transfer Equivalence Protocol Summary Report and Customer Summary Report
• Manage review and approval of TT documents on time
• Compiling and approval of Technology Transfer Gap Assessment if required
• Ensure West global tooling experts do assessment of tools conditions and gain for their recommendation about which tools will be used for production of the TT batches.
• Manage knowledge transfer between a sending and receiving site.
• Takes a new perspective using existing solutions to recommend and apply continues improvement and optimization of transfer processes and documentation templates
• Training of less experienced NetOp colleagues

• Minimum: Master’s in Engineering or Applied Sciences

• Strong analytical, communication, and interpersonal skills.
• Robust West Pharmaceutical product / process knowledge incl. Master Control & West Quality Systems.
• Lean Six Sigma Green Belt & Minitab software
• Strong extended project management skills with the ability to deploy solutions in a global environment.
• Influence - ability to influence effectively across multiple functions and regions
• Driving execution - through determining action steps and milestones required to implement a specific business initiative; adjusts activities or timelines as circumstances warrant.
• Customer oriented mindset

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• According to the principles of health and safety at work (substantiated by the Safety Leadership Statement), the job holder is aware of his/her particular responsibility regarding work safety and acts accordingly at all times
• Able to comply with the company’s quality policy at all times.
• The job holder is aware of his/her special responsibility for quality according to the company’s quality policy and conducts his/her activities in accordance with the company quality policy at all times.
• The job holder respects all specifications arising from the cGMP requirements and from the specifications DIN ISO 15378 and DIN EN ISO 9001 as per its current state and also as it applies to any future amendments. Support and contribute in Lean Sigma programs and activities towards delivery of the set target.

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and finger to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required at all times in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading or writing, organization, problem solving, understand direction, supervise and speak publicly, etc.