Mgr/TL Business Systems Validation

Pfizer • Kalamazoo, MI

13d • Onsite

About The Position

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.

Requirements

• High School Diploma (or Equivalent) and 10 years of relevant experience OR an associate's degree with 8 years of experience OR a bachelor's with at least 5 years of experience OR Master's 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
• Occasional lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
• Permanent work authorization in the United States.

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED