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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 position reports into the Quality Systems department and is responsible for implementation and management of Bristol Myers Squibb's GMP Data Governance and Data Integrity (DI) program at the Bothell, WA manufacturing facility.

Shift Available:

• Monday - Friday, Hybrid Day Shift

Responsibilities:

• Serve as the site DI subject matter expert (SME) and promote/train/coach site staff on ALCOA+ principles and associated worldwide regulations.

• Ensure site meets the expectations of the Global BMS Data Integrity program, including but not limited to the annual DI Master Plan, DI training curriculum ownership, and launching DI related initiatives to promote the DI culture within the organization.

• Ensure the validation, implementation and change management of e-systems used across the site operations are conducted in compliance with applicable Data Integrity related regulatory requirements (FDA, EMA, etc).

• Responsible for ensuring systems at the Bothell site comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g., data creation, data processing, review, reporting), data security, data traceability process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.

• Responsible for leading, reviewing, and approving data integrity assessments for GxP systems and processes including, but not limited to, manufacturing and laboratory systems/processes to ensure compliance with regulatory requirements and company established requirements for data integrity.

• Effectively partner with cross-functional stakeholders to ensure both systems and processes are DI compliant through governance and risk control, and drive mitigation/remediation actions when DI gaps are identified.

• Periodically report the Data Integrity metrics of the site through the Site Quality Management Review and to the Global DI COE.

• Collaborate with BMS Global Data Integrity Center of Excellence team to ensure adherence and alignment to Global DI policies and strategy as defined by the BMS Global DI program.

• Prepare and deliver communications to site leadership regarding risk, mitigations, data integrity metrics, and Global DI Program planning.

Knowledge & Skills:

• Demonstrated excellence in written and verbal communication.

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

• Demonstrated ability to work effectively with US FDA, EU and other regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and other applicable standards.

• Demonstrated expertise in Data Integrity principles and GxP knowledge with ability to recognize Data Integrity risks and develop mitigation plans.

• Demonstrated record with driving continuous improvement and fostering a compliant operational excellence culture.

• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a leader of team(s) to engage and influence team members in a matrixed environment.

• Demonstrated experience utilizing Risk Management tools (e.g. FMEA, FTA tools) to understand and reduce overall risks through effective CAPA planning and implementation.

• Experience performing site and functional audits and walk-throughs.

Basic Requirements:

• BS or higher degree in an IT, engineering, scientific discipline or other related field.

• 5 or more years of relevant work experience in pharmaceutical quality operations, quality assurance, quality systems, or compliance role.

• 5 or more years in a cGMP environment.

• At least 3 years in a leadership position.

• Expertise with 21 CFR Part 11, EU Annex 11 and GAMP standards for DI and validation of automated systems is required.

• Strong experience with computer systems and records for GMP operations.

Preferred Requirements:

• Computer systems validation experience.

• Strong quality systems knowledge.

• Strong ability to influence others.

• Project management experience.

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 .

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/ 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: R1583219

Updated: 2024-07-28 03:29:22.568 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.