Quality Site Leader - PGS Kalamazoo

Use Your Power for Purpose

Our science and risk-based quality culture is not only compliant but also flexible, innovative, and customer-oriented. 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 non-sterile drug products, including medical devices. The SQOL partners with Site Operations, Other Pfizer Sites, Co-Development, Analytical Research and Development and other stakeholders to 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, in-process 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, Co-Development 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 high-performance 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