MgrTL Business Systems Validation

Use Your Power for Purpose

Every day everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible innovative and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development maintenance compliance or analysis through research programs your contribution will have a direct impact on patients

What You Will Achieve

This position is for the Mgr/TL Business Systems Validation. The successful candidate will Lead the Business Systems Validation team to ensure that defined quality standards and objectives are met. This position acts to ensure oversight over and ownership of all Quality Business Systems at the Kalamazoo site. The role provides input for the development of site strategies in order to ensure compliance with global and regulatory expectations.

Ensures cost effective activities/programs are implemented in compliance with regulatory standards company policies practices and processes. Fosters teamwork and colleague development as well as change management within the department and the function.

Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values norms and behaviors. Provides oversight to individuals and team on personal development performance and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department ensuring proper use of assets budget and personnel.

How You Will Achieve It

In this role you will:

• Lead and manage people technology and financial resources within the department ensuring alignment with company core values SOPs and policies
• Actively share knowledge and identify potential improvements in processes or products taking risks to develop innovative ideas
• Solve moderately complex problems within your expertise and assist with issues outside the department providing technical guidance and oversight
• Oversee operational activities to support short-term goals and manage the performance of direct reports through goal setting coaching and ongoing assessment
• Solicit input explain complex concepts persuade others to adopt a point of view and effectively share your own perspective and rationale
• Oversee quality activities including change control systems product change control oversight and support non-manufacturing functions quality strategic planning and performance metrics
• Lead projects manage multiple ongoing work activities and provide leadership for Continuous Improvement initiatives focused on Quality System implementations and compliance performance
• Develop and implement fit-for-purpose and risk-based Good Manufacturing Practices (GMP) influence and monitor new internal requirements and ensure compliance with regulatory standards
• Act as the System owner for the site internal audit program organize and lead Site Inspection Readiness efforts participate in regulatory inspections and support initiatives to build and strengthen the quality culture within the site and Business Unit
• Understand quality and compliance systems including deviations change management validation documentation etc.
• Ability to drive change as required by the organization

Here Is What You Need (Minimum Requirements)

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience OR a PhD with 0 years of experience.
• Strong organizational and prioritization skills
• Critical thinking and analytical abilities
• Proficiency in People Management
• Adeptness with Quality Tracking System (QTS) for change management commitment tracking and manufacturing investigations
• Familiarity with Microsoft Outlook Excel PowerPoint and MS Project
• Solid understanding of GMPs and various GMP documentation types such as SOPs User Guides Master records and PTVAs

Bonus Points If You Have (Preferred Requirements)

• Thorough understanding and in-depth knowledge of local quality standards such as 21 CFR Part 4 820 ISO 13485 GAMP V and ISO 14971 along with related standards
• Sound understanding of continuous improvement tools and skills including standard work and visual management
• Excellent communication and interpersonal skills
• Experience in regulatory inspections and audit response preparation
• Experience using common AI tools including generative technologies such as ChatGPT or Microsoft Copilot to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices including risk management and ethical use
• Knowledge of Kalamazoo Site Business Systems
• Database querying knowledge
• Ability to understand/interpret customer requirements recommend/develop business solutions and ensure adherence to project timelines and budgets
• Demonstrate Project and or People Management skills
• Comfortable with providing both positive and improvement feedback
• Knowledge of GMP requirements for computerized systems and standard operating procedures

PHYSICAL/MENTAL REQUIREMENTS

Occasional lifting sitting standing walking bending ability to perform mathematical calculations and ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel may be required (<5%).

Work Location Assignment:On Premise

Last Date To Apply: June 26 2026

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process please review our candidate AI-use guidelines available onPfizer Careers.