Manager, IT Quality

5 days ago

Bothell, Washington, United States Bristol Myers Squibb Full time

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

The IT Quality & Compliance Manager 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 IT Quality & Compliance Manager 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.

Key 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

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.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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