Position SummaryThe 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.
Key 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.
Qualifications & Experience- 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.
Compensation Overview:Devens - MA - US: $89,530 - $108,490
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 https://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.
