Supplier Quality Senior Specialist

Bristol Myers Squibb • Devens, MA

4d • $89,530 - $108,490 • Onsite

About The Position

The Supplier Quality Senior Specialist is responsible for work which supports the GMP/GDP Vendor and Material Management programs at the Devens Biologics site. This includes vendor qualification and management, material qualification and management, change management and supplier related non-conformance reporting and resolution.

Requirements

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, or related discipline, or combination of education, experience and training.
• A minimum of 4 years direct experience in a regulated, biopharmaceutical environment or similar, is required.
• Practical knowledge of US and EU cGMP regulations and guidance and ISO standards.
• Familiarity with common electronic systems such as SAP, Veeva, and Syncade.
• Demonstrated work experience that reflects attention to detail, personal accountability, and a collaborative mindset that delivers results.
• Excellent written and oral communication skills are necessary.

Responsibilities

• Qualification and management of GMP/GDP vendors, including assessment of vendors, creation and revision of Quality agreements and maintenance of the Approved Vendor List.
• Lifecycle management of starting materials used for the manufacture of drug substance, including material qualification and requalification, reduced testing, and direct dispense.
• Assessment of supplier change notifications (SCN) and identification and completion of required actions within the BMS change management system.
• Assists with internal or external deviations, Supplier Corrective Action Requests (SCAR), and CAPA associated with nonconforming materials or services provided by vendors.
• Performs review of documents including standard operation procedures, technical documents / reports, agreements, qualifications, and forms.
• Executes oversight of on-site service vendors throughout the facilitiy in collaboration with the business owners and QA Operations.
• Exercises sound decision making within generally defined processes to select methods for resolving routine work.
• Identifes risks to Quality and business continuity and applies appropriate notification to management as appropriate.
• Collaborates with cross-functional site and network stakeholders with a concise and solution oriented approach.
• May represent the team on cross-functional projects and initiatives related to suppliers and materials.
• May participate in external audits as a support team member under supervision of the lead auditor.

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior