Supplier Quality Manager

Bristol Myers Squibb • Devens, MA

16h • Onsite

About The Position

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. Read more: careers.bms.com/working-with-us .

Requirements

• 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.
• 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.

Nice To Haves

• Experience in managing the quality of suppliers providing raw materials, consumables and services for biologics bulk drug substance manufacturing is highly preferred.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• As LPO or SME maintain site readiness for regulatory inspections and interact with inspectors in response to requests as required.
• Collaborate within the Supplier QA team, cross-functionally, and with Global Process Owners to continuously improve processes, innovate, and contribute to predictive compliance.
• Support external audits as needed.
• Perform quality review and approval of functional area documents including Standard Operation Procedures, technical documents, risk assessments, reports, agreements, and qualifications.
• 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.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees