Manager, IT Quality & Compliance

$92,000 - $115,000/Yr

Bristol-Myers Squibb - Bothell, WA

Full-time - Mid Level

Hybrid - Bothell, WA

Chemical Manufacturing

About the position

The IT Quality & Compliance Manager at Bristol-Myers Squibb is responsible for leading compliance-related activities for GxP electronic systems and applications. This role involves managing quality systems deliverables throughout their lifecycle to ensure regulatory compliance, partnering with various stakeholders, and supporting regulatory inspections. While primarily an individual contributor, the manager may oversee contract resources as needed.

Responsibilities

• Manage department (IT) metrics reporting linked to regulatory compliance and Quality Events, including Deviations, CAPAs, Change Requests, Training, and completion of applicable procedural requirements.
• Perform / lead investigations and root cause analyses for Quality Event deviations related to IT systems.
• Author / contribute content, review and approve applicable Quality Systems records, including Deviations, CAPAs, Change Requests, SOPs, and others as needed.
• Partner with Quality, and Business / Technical Owners on continuous improvement efforts to reduce or eliminate adverse trends related to Quality Events impactful to IT.
• Perform periodic reviews of applicable SOPs.
• Participate in governance boards, acting as the IT representative for regulatory and procedural compliance.
• Support regulatory inspections as a subject matter expert (SME) as needed.
• Manage supporting contract resources as needed.
• Assist with site integration and enterprise harmonization activities as applicable.

Requirements

• Experience in IT quality management and compliance in a regulated environment.
• Strong understanding of GxP regulations and quality systems.
• Ability to perform root cause analysis and investigations.
• Excellent communication and collaboration skills.

Nice-to-haves

• Experience with electronic systems and applications in a clinical or manufacturing setting.
• Knowledge of regulatory inspection processes.
• Project management experience.

Benefits

• Competitive salary range of $92,000 - $115,000 per year.
• Incentive cash and stock opportunities based on eligibility.
• Comprehensive health insurance coverage.
• Flexible work environment options.
• Professional development opportunities.