Associate Manager, Product Quality

Stryker is seeking an Associate Manager, Product Quality to support our Medical division at Sage in Cary, IL. This role provides leadership for commercial product quality activities across the product lifecycle, ensuring the continued quality, safety, compliance, and performance of marketed pharmaceutical, cosmetic and medical device products.

• Provide oversight and continuous improvement of product complaint handling, stability program, product quality reviews, and product health risk assessments. Ensure product quality monitoring activities are performed in compliance with applicable US and International regulations. Passionately drives team to execute initiatives and projects to enhance product quality performance for our customers.
• Lead commercial product quality activities, including product complaint handling, stability program, product quality reviews, and product health risk assessments.
• Ensure product complaints are appropriately evaluated, investigated, trended, escalated, and closed in accordance with regulatory requirements and internal procedures.
• Lead and continuously improve the stability program, including study design, execution, monitoring, reporting, and data review activities, while ensuring compliance with ICH, FDA, and global regulatory requirements.
• Coordinate and support product quality reviews (PQRs) and other product quality monitoring activities to assess product performance and maintain a state of control.
• Analyze and trend complaint, stability, investigation, and product quality data to identify emerging risks, recurring issues, and opportunities for continuous improvement.
• Ensure compliance with corporate policies and procedures regarding product complaint handling, stability program, product quality reviews, and product health risk assessments.
• Develop and maintain quality metrics, e.g., Key Process Indicators (KPIs), dashboards, and management reports that support effective product quality oversight and data-driven decision making.
• Support in regulatory and internal audits on matters relating to product complaint handling, stability program, product quality reviews, and product health risk assessments.
• Influence cross-functional teams; such as Regulatory Affairs, Marketing, Sales, Manufacturing, R&D, Supply Chain, and Quality teams, to address product quality related inquiries.
• Identify and implement corrective actions to ensure the continued quality, safety, and performance of marketed pharmaceutical, cosmetic and medical device products
• Build, lead, and develop a high-performing team by setting clear goals and performance expectations, coaching and addressing performance, while recruiting, onboarding, and retaining top talent to foster a culture of accountability, collaboration, continuous improvement, and strong business results.

• Bachelor of Arts (BA) or Bachelor of Science (BS) in a science, engineering, or related discipline is required.
• Minimum of 6+ years of experience in quality engineering, stability programs, quality assurance, product quality, post-market quality, quality systems, or related commercial quality functions in a regulated environment is required.
• Proven experience in quality management and system improvements.
• Experience managing or supporting product complaints, investigations, CAPAs, quality system processes, and quality monitoring activities.
• Experience overseeing or supporting pharmaceutical stability programs.
• Strong understanding of:
• cGMP requirements
• FDA regulations
• ICH guidelines
• Product complaint management
• Stability programs
• CAPA systems

• Minimum of 3+ years of supervisory experience with demonstrated people‑leadership exposure, including mentoring, training, and developing high‑performing direct and…