Job Description

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. 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.

Key Responsibilities:

1. Subject Matter Expert (SME) and/or Local Process Owner (LPO) for Vendor Qualification and Management. Manage lifecycle activities of qualification and routine oversight of GMP and GDP vendors. This includes assessing new vendors, developing and revising Quality Agreements, providing input to the vendor risk assessment and audit program, and maintaining accurate data within the Approved Vendor List in the electronic Supplier Quality Management system.
2. Subject Matter Expert and/or Local Process Owner for Material Qualification and Management. Manage the lifecycle activities of materials used for the manufacture of drug substance, which involves material qualification, maintenance/control, reduced testing, and direct dispensing.
3. Conduct timely impact assessment of supplier change notifications and ensure actions are prioritized and driven to completion utilizing the change management system to ensure business continuity.
4. Facilitate nonconformance reporting and resolution via Supplier Corrective Action Request (SCAR), deviation, and Corrective and Preventive Actions (CAPA) as appropriate related to materials or services provided by vendors.
5. Manage the process for quality oversight of on-site service vendors, collaborating closely with cross-functional partners that frequently engage these service vendors, such as Facilities & Engineering.
6. As LPO or SME maintain site readiness for regulatory inspections and interact with inspectors in response to requests as required.
7. Collaborate within the Supplier QA team, cross-functionally, and with Global Process Owners to continuously improve processes, innovate, and contribute to predictive compliance.
8. Support external audits as needed.
9. Perform quality review and approval of functional area documents including Standard Operation Procedures, technical documents, risk assessments, reports, agreements, and qualifications.
10. Coordinate and lead meetings with site stakeholders, other network sites, and external partners concerning vendor and material management programs, including discussions, negotiations, and dispute resolution.

Qualifications & Experience:

• Knowledge obtained through formal education resulting in a Bachelor of Science (B.S.) degree in a field such as science, engineering, biochemistry, or a related discipline, or a suitable combination of education, experience, and training.
• A minimum of 6 years of relevant experience within a regulated environment, including at least 4 years concentrated on product quality, is essential.
• Experience in managing the quality of suppliers providing raw materials, consumables and services for biologics bulk drug substance manufacturing is highly preferred.
• Comprehensive knowledge of cGMP regulations and guidelines in the US and EU.
• Familiarity with Quality Risk Management principles.
• Proficient understanding of electronic Quality Management Systems such as TrackWise or Veeva/Infinity.
• Prior work experience where attention to detail and personal accountability were crucial to success.
• Experience collaborating in a team-oriented environment with a diverse group of individuals.
• Exceptional writing and verbal communication skills are required.

Devens - MA - US: $105,330 - $127,638

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. 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 careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:

• Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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 adastaffing

Job Tags

Hourly pay, Full time, Temporary work, Part time, For contractors, Work experience placement, Summer work, Work at office, Local area, Remote work, Flexible hours, Shift work,

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