Associate Manager, Product Quality

Work Flexibility: Hybrid or Onsite

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.

What you will do

• 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.

What you need

Required

• 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

Preferred

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

• Master of Arts (MA) Master of Science (MS) Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) preferred.

$112900 - $188100 USD Annual

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.