Associate Manager, Product Quality

Stryker • Cary, IL • 1h ago

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 people-leadership exposure, including mentoring, training, and developing high-performing direct and indirect reports

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

$112,900 - $188,100 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.

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