Product Quality Leader, Lifecycle & Compliance

Stryker Group; Cary (IL); On-site; USD 113,000 - 188,000; Full time

Job summary

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.

The successful candidate will oversee product quality programs, collaborate with Regulatory Affairs, Marketing, Sales, Manufacturing, R&D, Supply Chain,

Qualifications

• Bachelor degree in science, engineering, or related discipline.
• 6+ years in quality engineering or related functions in regulated environment.
• Experience in quality management and system improvements.
• Experience managing product complaints, investigations, CAPAs, quality monitoring.
• Experience overseeing pharmaceutical stability programs.
• Strong knowledge of cGMP, FDA, ICH, product complaints, stability programs, CAPA.

Responsibilities

• Oversee and improve product quality activities across lifecycle for marketed products.
• Lead cross-functional teams to address quality issues and regulatory compliance.
• Develop and maintain quality metrics, dashboards, and management reports.

Skills

Quality engineering

Stability programs

Quality assurance

Product quality

CAPA systems

Education

BA/BS in science or engineering

Job description

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.

The successful candidate will oversee product quality programs, collaborate with Regulatory Affairs, Marketing, Sales, Manufacturing, R&D, Supply Chain,