Supplier Quality Senior Specialist - Devens, MA

VetJobs; Harvard (MA); On-site; USD 75,000 - 100,000; Full time

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Supplier Quality Senior Specialist to support GMP/GDP vendor and material management programs. The role involves vendor qualification, material qualification, change management, and handling supplier-related non-conformances.

You will collaborate with cross-functional teams, perform document reviews, oversee on-site service vendors, and participate in audits. The position requires a BS degree and at least 4 years of regulated biopharmaceutical

Qualifications

• BS in science, engineering, biochemistry, or related field.
• Minimum 4 years in a regulated biopharmaceutical environment.
• Knowledge of US/EU cGMP regulations and ISO standards.
• Experience with SAP, Veeva, and Syncade.
• Excellent written and oral communication.

Responsibilities

• Qualify and manage GMP/GDP vendors and maintain the Approved Vendor List.
• Oversee starting materials lifecycle for drug substance manufacturing.
• Review supplier change notifications (SCN) and drive required actions.
• Support deviations, SCARs, and CAPAs for nonconforming materials.
• Review SOPs, technical documents, agreements, and forms.
• Coordinate on-site vendor oversight with QA Operations.

Skills

Attention to detail

Written and oral communication

Collaboration

Regulatory knowledge

Education

Bachelor's degree

Tools

SAP

Veeva

Syncade

Job description

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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.

Position Summary

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.

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.

Minimum Education Required

Bachelors

Additional Qualifications/Responsibilities

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.

City

Devens

State

Massachusetts

Job_Category

Health/Medical other

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Bristol Myers Sqibb BMS

Salary Range

$75,000-$100,000