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Title:  Sr Manager Data Integrity

Requisition ID:  63788
Date:  Feb 8, 2024
Location: 

Exton, Pennsylvania, US

Department:  Quality
Description: 

 

Hybrid role at Exton, PA. Candidates applying must be within a 50 miles radius to the location or be willing to relocate to job location.

 

Who We Are:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary

This role will be responsible for implementing and leading a West cross-functional program on Data Integrity (DI), Data Management and support of the paperless enterprise strategic goal. This role will be tasked to implement DI management standards across West. This role will have management responsibilities for the Data Integrity program and its associated projects. Management and execution of Computer System Validation projects will also be a focus of this role.

 

Essential Duties and Responsibilities

  • Leads a Data Integrity program, including Project Management, Budget, Resource Planning, and Communication Plans
  • Responsible for management of people and cross functional teams to ensure effective collaboration and achievement of objectives.
  • Supports assigned functions to bring systems and processes into compliance with GMP and DI principles as well as the continuing maintenance of DI.
  • Mentor, develop and evaluate team members to foster their potential and achieve priorities.
  • Supports and continuously improves procedures and processes related to but not limited to computerized system validation, Excel spreadsheets, data archival, system backup and restoration, and audit trail review
  • Establishes a communication strategy for typical customer questions on DI, e.g. during audits, and educates the relevant functions accordingly
  • Closely monitors regulatory developments and new guidelines in the area of DI and drives their implementation
  • Proactively identifies opportunities for continuous improvement of DI compliance and paperless enterprise
  • Writes, reviews, approves Computer System Validation deliverables
  • Collaborates with internal stakeholders
  • Other duties as assigned

 

Basic Qualifications

  • Bachelors Degree in Science or IT related Discpline 
  • Minimum 10 years of professional and management experience in GMP regulated environment 
  • Minimum 10 years of writing, reviewing, executing and approving Computer Systems Validation deliverables

 

Preferred Qualifications

  • Experience in leading global and cross functional projects
  • Experience with SAP, LIMS, MES, SCADA, QMS

 

Travel Requirements

  • Upto 20% travel 

#LI-DJ1

 

 

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.  

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