Quality Site Leader - PGS Kalamazoo

Use Your Power for Purpose

Our science and riskbased quality culture is not only compliant but also flexible innovative and customeroriented. Whether you are engaged in development maintenance compliance or analysis through research programs your contribution will have a direct impact on patients. Your leadership and expertise will drive the strategic direction of your division fostering a culture of continuous improvement and innovation. Your ability to leverage constructive relationships across divisions will help you maximize the resources available within the organization ensuring that Pfizer is ready to achieve new milestones and help patients across the globe.

What You Will Achieve
The Site Quality Operations Leader (SQOL) is responsible for the operational and strategic management of a diverse range of quality control quality assurance and quality system operations to support Clinical and Commercial manufacture for small molecule APIs biologic drug substances and sterile and nonsterile drug products including medical devices. The SQOL partners with Site Operations Other Pfizer Sites CoDevelopment Analytical Research and Development and other stakeholdersto drive regulatory excellence ensures a supply of quality products from the site which are compliant with regulatory requirements to meet customer needs and develops talent.
The SQOL is accountable for the product quality regulatory compliance quality systems and processes for the site (including 3rd parties under the responsibility of the site). The scope of this role also includes quality budget and resources planning quality performance metrics/quality dashboard quality strategic planning quality goals and objectives and quality specific projects. The SQOL is accountable for providing leadership to the site in establishing compliance with marketing authorizations of all materials packaging components inprocess and final commercial products with established specifications compliance with regulations and other applicable standards. The incumbent is also responsible for working closely with Pfizer Global Supply (PGS) Worldwide Research and Development (WRD) and Global Regulatory Affairs (GRA) teams to develop strategies on new product introduction for diverse new products.

This position will have a dual reporting relationship to the Kalamazoo Site Leader and the OpU Quality Operations Leader and will be a member of both the Kalamazoo Site Leadership Team (SLT) and the Cluster 3 Quality Leadership Team.

Position Responsibilities
Relationships: Achieves compliance and business results through Partnerships between Quality and Operations and other site/cross site functions e.g PharmSci Regulatory CoDevelopment teams etc. Is an active member of the Site Leadership Team.
High Performance Culture: Creates a high achieving Quality Operations team with goals and values aligned with other team members and operations collaborative team environment and highperformance culture within the site Quality Operations organization.
Operational Excellence: Drives innovation and continuous improvement through Operational Excellence(OE) in all QO activities and supports OE throughout the site.
Talent Management Focus: Oversees the conduct of Talent Management programs to develop future Pfizer leaders and the creation of robust succession plans for the Site Quality Operations Organization. Directs oversees and participates in the recruitment selection promotion termination and performance management of site personnel in leadership and critical roles. Leads the following activities:
Job Descriptions for Reports
Training curricula/records
Development Plans
Performance Appraisals
Coaching of Direct reports
Safety: Ensures that all QO operations are performed in a safe environment in accordance with all applicable EHS policies and procedures.
Issue Resolution: Ensures the creation and implementation of clear and timely action plans for issue resolution with appropriate escalation communication and closure.
Regulatory Excellence: Ensures sustainable regulatory excellence through systems science people and continuous process improvements. Ensures a favorable site regulatory profile through constant inspection readiness programs; ensures successful Board of Health inspections. Creates effective relationships with BOH to create trust and credibility. Prepares the site for changes to regulations.
Quality Systems: Ensures compliant site Quality Systems and marketing authorizations.
PQS: Responsible for the implementation of all Pfizer Quality Standards and ensures objectives and action plans that are not already included in the above accountabilities.
ICH and Industry Standards: Drives understanding of ICH Q8 Q9 Q10 and other appropriate industry standards across the site organization. Follows actively and anticipates impact of emerging regulations on site operations and prepares site for implementation and change as appropriate
Product Disposition: Ensures independent and timely product disposition using validated processes analytical methods and documented decisionmaking processes.
Quality Technical Support: Fosters science through the establishment and work of the Quality Technical Support function
Technology and Science: Holds self and others accountable for making decisions solving problems or driving improvements through a sound understanding of the technology and science of the products.
Quality System: Ensuring the quality system requirements are effectively established and effectively maintained in accordance with regulatory compliance. Ensures the quality policy is disseminated across all levels of the organization.
Reporting on the performance of the quality system to Management with Executive Responsibility including the adequacy and effectiveness of the quality management system and any need for improvement.
Ensuring that the processes needed for the quality management system (QMS) are documented.
Regulatory Compliance: Ensuring the promotion of awareness of the applicable Regulatory Compliance and QMS requirements throughout the organization.

Here Is What You Need (Minimum Requirements)
12 or greater years of manufacturing quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
Greater than 10 years of Quality Operations experience and familiarity with Drug Product manufacturing. API experience preferred.
Experience leading people leaders and directing a large complex organization. Previous Site Quality leadership experience preferred
Experience influencing Board of Health inspections and successful interactions with inspectors preferred
Ideal candidates will have prior experience and demonstrated success in most if not all of the following:
Making sound and effective decisions under pressure
Managing a Quality/Operations function with product release responsibilities
Experience in at least two quality and/or science areas
Working in functions outside Quality/Operations e.g. Technology Validation Operations Regulatory
Working with other manufacturing and R&D sites to understand a broader perspective
Exposure to Regulatory inspections including interactions with Board of Health representatives and responding to Board of Health observations
Working with multicultural crossfunctional work teams
Advancing a quality culture in a manufacturing environment
Evaluating and continuously improving site Quality Systems
Managing managers and teams
Project management
Finance planning and budgeting
Developing and implementing a quality business strategy
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Bonus Points If You Have (Preferred Requirements)

• A masters degree with relevant pharmaceutical experience particularly in Aseptic operations and Medical Device/Combination Products

• Demonstrated success in planning implementing and achieving significant and complex goals and objectives

• Deep understanding of US European and global cGMPs compliance issues inspectional trends and industry quality assurance practices

• Ability to exercise foresight and judgment in initiating planning organizing and guiding complex projects in unprecedented situations

• Innovative ideas and creative decisionmaking skills

• Ability to leverage constructive relationships across divisions

Physical/Mental Requirements

Ability to stand for 1 hour at a time sit for 2 to 3 hours at a time walk long distances and bend to obtain items from lower shelving/cabinets

NonStandard Work Schedule Travel or Environment Requirements

Primarily standard work hours with some exceptions to meet business needs. Some travel will be required to support network and sister site initiatives; 10 required travel.

Work Location Assignment:On Premise

Other Job Details

• Last Date to Apply: April 28 2025

The annual base salary for this position ranges from $204700.00 to $341100.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 22.5 of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 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 and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits . Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

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

Quality Assurance and Control

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