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.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

This role is part of the sites Quality Systems team and is responsible for implementation, management and monitoring of the sites Quality Risk Management (QRM) and Change Management program. This individual works cross-functionally and within the network to evaluate system performance and ensure relevant process improvements are identified, documented and implemented to mitigate process, product and / or system risks. This includes metric gathering, providing site guidance, and administrating site QRM and change control governance meetings.

Shift Available:

• Monday - Friday, Onsite Day Shift

Responsibilities:

• Provide site-level system information to customers, management and stakeholders regarding the status of Deviation and CAPA deliverables.

• Contribute to the coordination, writing, review, approval and maintenance of associated Standard Operating Procedures (SOPs) and Work Practices.

• Develop and conduct user training for the QRM and Change Management process to site personnel.

• Prepare metrics and interpret the data in preparation for support of Site and Global Quality Council. This may require the use of relational databases and / or reporting tools to collate and analyze quality data.

• Monitor and report system health metrics for the QRM and Change Management program at Bothell.

• Facilitate planning, execution and completion of risk assessments by providing guidance to cross-functional team members.

• Conduct risk reviews and escalate findings, as appropriate, to QRM team.

• Administrate scheduled and ad-hoc QRM and change management governance meetings including scheduling, building agenda, and issuing meeting minutes.

• Facilitating process improvements to the site QRM and change control process.

• Proactively deploy methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management and Change Management program.

• Develop and / or improve routine and ad hoc Quality Systems metric reporting for trending, performance deficiencies and conformance to KPIs.

• Partner with functional areas and counterparts across cell therapy network in identifying and/or harmonizing metrics that support daily operations of the Quality Management System.

• Support internal and external audits and regulatory inspections and audits.

• Support corporate and site-level requests for compliance and regulatory data.

• Represent the Quality unit at various project meetings and provide quality input in the resolution of system-related issues.

• Ensure that any changes or impacts to the systems are evaluated and communicated to the site.

Knowledge & Skills:

• Knowledge and experience with Quality Risk Management and Change Control.

• Previous work experience related to measuring quality system performance and data analysis.

• Strong project planning and management skills.

• Understanding of Quality Risk Management principles and application within the quality systems.

• Strong technical writing skill set and ability to critically review reports while effectively expressing Quality principles.

• Ability to work effectively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.

• Innovative, proactive, and resourceful; committed to quality and continuous improvement.

• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.

• Experience interacting with FDA or other regulatory agencies.

• Strong knowledge of cGMPs and Health Authority requirements.

• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems).

• Must be able to self-direct, multi-task, and clearly communicate to the manager of decisions outside of established processes and the ability to build a cross functional network.

Basic Requirements:

• Bachelor's degree or equivalent certificates and experience will be considered.

• 5-7 years of experience in GMP.

• 5-7 years of experience in change management.

• 5-7 years of experience in Risk Management.

• 5-7 years of experience in Quality Systems.

• 5-7 years of experience in Change Management.

• 5 years of experience within a Quality role.

• 3-5 years of experience in Project Management.

Working Conditions:

• Equipment Usage During Work Period: Computer 80%; Phone and Electronic Devices 20%.

• Sitting at a computer terminal for an extended period of time.

• Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone keyboard reach.

• Requirement to work in a conference room / meeting environment for moderate periods of time.

• Occasional periods in labs or production area, requiring some level of gowning. *This role is not expected to work in labs or production areas. It would be on rare occasions this person would have to gown (maybe for tours, GEMBA walks, etc. but that’s on a rare occasion).

• Light to moderate lifting.

• Regular, predictable attendance is required, plus occasional overtime, as business demands dictate.

• Moderate noise i.e., business office with computers, phone, and printers.

The starting compensation for this job is a range from $127,000 to $159,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site (https://careers.bms.com/working-with-us) .

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical,

pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).

Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility 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.

Company: Bristol-Myers Squibb

Req Number: R1581207

Updated: 2024-05-29 03:54:48.769 UTC

Location: Bothell-WA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.