Sr Manager Data Integrity / CSV

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  
Education:

 

• Bachelor's Degree in Science or IT related discipline required    

 
Work Experience

 

Required:

 

• Minimum 10 years professional and management experience in GMP regulated environment required  
• Minimum 10 years  writing, reviewing, executing and approving Computer Systems Validation deliverables.required   

Preferred:

 

• Experience in leading global and cross-functional projects   
• Experience with SAP, LIMS, MES, SCADA, QMS is desired       
• KSAs
• Proficiency in English, additional languages are a plus
• Project management
• Comply with relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Comply with the company’s safety policy at all times
• Comply with the company’s quality policy at all times.

 
Travel Requirements

 

• 20%: Up to 52 business days per year

 
Physical Requirements