[Hiring] Senior Engineer, IT Compliance @Bristol Myers Squibb

Role Description

The Sr. Engineer, IT Compliance works cross-functionally to lead compliance-related activities for GxP electronic systems and applications. This role is primarily an individual contributor but may manage supporting contract resources periodically. The Engineer, IT Compliance will partner with Quality, Business Owners, and Technical Owners to create and manage Quality Systems deliverables for electronic systems and applications throughout their lifecycle to ensure regulatory and procedural compliance, supporting the site’s right to operate.

• 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.

Working Conditions

• Work will be performed in a normal office environment (or remotely) as well as cell therapy manufacturing areas, server rooms, data closets, and warehouses.
• Must be able to don appropriate gowning for entering cell therapy manufacturing and testing areas in accordance with company procedures.
• Normal office temperatures and lighting conditions will apply.
• Must be able to lift up to 25 pounds.
• Must be able to sit for extended periods.
• Must be able to stand for extended periods.

Education

• Bachelor's degree in a life sciences, engineering, or technology discipline, or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.

Experience

• 2+ years of direct experience with Quality Systems (Deviations, CAPAs, Change Requests, SOPs) related activities, with a demonstrated understanding of electronic records / signatures and application of the ALCOA+ principles of data integrity.
• Strong knowledge of global Health Authority regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records, and electronic signatures.
• Strong knowledge of Quality Systems records documentation and metrics reporting.
• Familiar with an array of computerized systems: MES, ERP, LIMS, Validation Lifecycle / Testing Software, QMS, Learning Management System.

Compensation Overview

Bothell - WA - US: $99,480 - $120,551. The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule, and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life, and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.