Computer System Program Senior Manager

Use Your Power for Purpose

At Pfizer, we believe that every role contributes to our mission of improving patients' lives.Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world.

What You Will Achieve

Responsible for ensuring that all Enterprise Computerized Systems are in full compliance with regulatory requirements, company policies, and procedures at the Pfizer Andover site. This role provides compliance leadership, direction, and execution in computer system program management for new projects and existing systems.

In this role, you will:

• Oversee the program management of Enterprise Computer Systems to ensure they meet industry and regulatory standards and are fit for their intended use at the Pfizer Andover site. This includes developing and maintaining validation plans, protocols, and reports, as well as coordinating with various departments to ensure alignment with the Validation Master Plan are completed on time and within budget. Ensure all computerized systems comply with regulatory requirements, including FDA 21CFR820, FDA 21CFR11, GAMP, and other applicable regulations.
• Act as the business owner for select site applications responsible for managing and maintaining systems per site needs.
• Planning and performing of Computer Systems Validation (CSV) in the regulated environment in collaboration with the site groups.
• Advisory and support of application owners to build and maintain GxP conforming systems and ensure compliance with applicable regulations and industry standards.
• Development and implementation of procedures that adhere to Data Integrity requirements as defined in applicable regulations.
• Oversee and perform computer system program management activities and ensures the approach and execution aligns to applicable regulations, GAMP 5, and Pfizer’s directives and procedures.
• Develop/enhance and implement Computer Systems Validation documentation such as protocols, test scripts, assessments, reports, SOPs, policies.
• Support the implementation and adoption of the global CSV program and remediation.
• Support data integrity implementation and remediation for systems within CSV program.
• Participate in audits and continuous improvement efforts related to CSV program.
• Manage CSV project teams to achieve site and global goals and directives.

Here Is What You Need (Minimum Requirements)

• BS engineering or science with 6+ years of experience in validation activities supporting manufacturing and development operating in regulated environment or equivalent.
• Direct experience with IT and/or Engineering automation systems supporting GMP manufacturing.
• Communication Skills: Excellent written and verbal communication skills to effectively collaborate with cross-functional teams and present validation findings.
• Problem-Solving: Strong analytical and problem-solving skills to identify and address validation issues.
• Leadership: Ability to lead and mentor team members, providing guidance and support as needed.
• Ability to work both independently and cross-functionally with IT and Site organizations in a dynamic, ever-changing environment.

Bonus Points If You Have (Preferred Requirements)

• Direct experience implementing CSV activities to support GxP systems.
• Strong knowledge of FDA and cGMP regulations and documentation practices.
• Strong knowledge of GAMP 5.
• Strong knowledge of 21 CFR Part 11 and Annex 11.
• Strong knowledge of computer system validation methodologies.
• Understanding of modern and risk-based validation executions.
• Project Management: Ability to manage multiple projects simultaneously, ensuring timely and successful completion.
• Experience managing cross-functional teams and external vendors.

  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Standard M-F work week

• None/little travel

• Occasional off-shift requirements

• Work Location Assignment: Hybrid

The annual base salary for this position ranges from $120,800.00 to $201,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to partici