Associate Quality Manager, Stability

Stryker is seeking an Associate Quality Manager Stability to support our Stryker Sage Medical division in Cary IL to provide leadership for the Stability function overseeing team performance processes and procedures while advancing quality excellence across the product lifecycle. This role ensures compliance with U.S. and international regulatory requirements and supports quality activities from product development through commercial manufacturing and postmarket surveillance.

What you will do:

• Lead and continuously advance a bestinclass Stability program ensuring compliance with global regulatory requirements (ICH FDA ISO) and inspection readiness at all times

• Provide strategic and operational oversight of stability study design execution monitoring and reporting including support for regulatory submissions and product quality reviews

• Establish maintain and improve stability policies procedures systems and documentation to drive consistency scalability and data integrity

• Analyze stability data and trends to proactively identify risks mitigate issues and drive continuous quality and product lifecycle improvements

• Plan prioritize and oversee team deliverables; monitor progress and assess results to ensure alignment with organizational and business objectives

• Partner crossfunctionally with Quality Regulatory R&D Manufacturing and Supply Chain to ensure alignment effective decisionmaking and timely outcomes

• Build and lead highperforming teams by setting clear goals KPIs and performance expectations; coach develop and address performance to maximize engagement and results

• Recruit onboard and retain top talent while fostering a culture of accountability collaboration and continuous improvement

What you need:

Required

• Bachelors degree in a Science Engineering or related

• Minimum of 6 years experience - supporting Pharmaceutical Quality Control and Quality Assurance functions with demonstrated success driving quality improvements through data and quality system improvements.

• Deep expertise in pharmaceutical stability testing aligned with ICH and global regulatory standards supported by comprehensive knowledge of diverse analytical techniques and instrumentation.

• Proven ability to analyze complex data sets using sound mathematical and statistical principles to inform decisions and drive effective executable actions

Preferred

• 3 supervisory experience with demonstrated peopleleadership exposure including mentoring training and developing highperforming direct and indirect reports

• Quality Engineer (ASQ CQE) Certification preferred.

• Demonstrated ability to effectively communicate and influence stakeholders at all levels of the organization with proven success working in crossfunctional team environments