West Pharma Sr Manager Digital Quality 

United States, Arizona, Scottsdale 

21080135

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

Education:

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

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

Sedentary exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. West Pharmaceutical Services is an Equal Opportunity Employer.