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Title:  Senior Manager Global Net Ops

Requisition ID:  52182
Date:  Aug 5, 2022
Location: 

Exton, Pennsylvania, US

Department:  Operations
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

Lead and manage incoming and outgoing Technology Transfers for the Global Sites as assigned to the timelines and objectives established.  Ensure that the Receiving Site can produce product that is equivalent to the Sending Site.  Execute utilizing West Project Management Best Practice.  Coordinate and lead knowledge transfer between the Sites. Take accountability in working with customers, plant and corporate resources to ensure key strategic projects are executed on time.

 

Essential Duties and Responsibilities:

Sending Site:

  • Complete Section 6 of “Requirements for Technology Transfer” document which includes Certifications, Customer Specifications, Packaging Requirements, Special testing, and lists the customers impacted
  • Provide all requested information and documentation to the Receiving plant by leading the necessary data gathering and process flow maps down to the individual material sku level.
  • Provide necessary documents (SOI / SOP / Customer information / Claims history / CAPA, etc)
  • Complete specific sections of the Technology Transfer Risk Assessment (TTRA)
  • Provide knowledge transfer to receiving site.
  • Coordinate with the Regional  NetOP Lead and Site Director to ensure necessary resources are in place
  • Document all in Change Control and in Project Management AIM site and support Receiving site in preparation of weekly to monthly status updates
  • Ensure local documentation of the Project (Resources / Cost / Travel expenses / Risks / Achievements)

Sending and Receiving Sites:

  • Work with the validation team and process engineering SME’s (Subject Matter Experts) to determine the validation process and at what level of the design
  • Conduct the joint Risk Assessment with QA, Operations, SME’s, and Supply Chain per the TTRA in conjunction with established FMEA’s that are already in place.
  • Implement and agree upon strategies to mitigate the risks/differences identified in the TTRA ensuring that the Receiving Site can produce equivalent product
  • Establish the operational parameters, CQA’s, and acceptance criteria to be evaluated
  • Join monthly technical customer facing meetings to ensure customer requirements are met and assist with customer engagement where required
  • Execute the TTEP
  • Review, remediate, and close-out any deviations and issues found as part of the TTEP
  • Manage the approval of the TTEP with QA and Operations
  • Recommend continuous improvement and optimization of the Tech Transfer process

Receiving Site:

  • Manage each project encompassing all aspects of the Transfer (items, customers, capacity, transportation, quality, regulatory, laboratory, technical)
  • Work with the Regional Technical Transfer Lead and Supply Chain to determine the full scope of the items and customers as part of the Transfer
  • Write the Project Charter and develop any necessary PER requirements in coordination with the Regional NetOP Lead
  • Initiate the “Requirements for Technology Transfer” document
  • Responsible for opening the Change Control and the initiation of the documentation in Master Control with the cross functional team including QA and Data Governance.
  • Initiate the Technology Transfer Risk Assessment using the TTRA form
  • Prepare the Technology Transfer Equivalency Protocol (TTEP) document defining documentation, references, test procedures, and acceptance criteria
  • Submit samples to the sending plant for equivalency certification
  • Work with QA to prepare the Customer Summary report
  • Close the Change Control with all related documents and forms
  • Document all in Change Control and in Project Management AIM site and prepare weekly to monthly status updates
  • Coordinate with the Regional  NetOP Lead and Site Director to ensure necessary resources are in place
  • Ensure local documentation of the Project (Resources / Cost / Travel expenses / Risks / Achievements)

General:

  • Communicates with internal and external stakeholders to ensure that client commitments are followed through during design and deployment.
  • Ensure the use of Program Management Best Practices to manage overall scope, time, and budget. Drive accountability and execute programs to achieve committed milestones & deliverables.
  • Lead and support continuous improvement projects throughout the global containment organisation.  Projects should be focused on waste reduction and generate cost savings through operational efficiency gains.
  • Maintain clear communication paths with all functional stakeholders.
  • Co-chair timely, efficient and action-oriented Project Team meetings and responsible for coordinating highly complex team operations and communication.
  • Conforms with and abides by all country specific regulations, policies, work procedures, instruction, and all safety rules.

 

 

Basic Qualifications: 

 

  • Education or Equivalent Experience: Bachelor's in Chemical/Electrical/Mechanical/Industrial Engineering or other Science based program, Finance, Supply Chain Management
  • Experience: 8-10 years of experience

Robust West Pharmaceutical product/process knowledge incl. Master Control & West Quality Systems

 

Preferred Knowledge, Skills and Abilities:

  • Strong 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 specific business initiative; adjusts activities or timelines as circumstances warrant.
  • Customer Intimacy
  • Collaboration
  • Business savvy
  • Relationship building and contributing to team success
  • Strong analytical, communication, and interpersonal skills.
  • Conflict Management
  • Ability to work in a matrix environment

 

Travel Requirements:

 

  • Up to 20% travel – intra-region and to other regions
  • Manage working with colleagues in a different time-zone

Physical & Mental Requirements:

  •  
  • Manufacturing environment up to 20% of the time.
  • Must be able to demonstrate excellent communication skills, both written and verbal.

 

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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