Supplier Quality Manager

Posted 19 Days Ago
Be an Early Applicant
Devens, MA
Senior level
Healthtech
The Role
The Supplier Quality Manager oversees vendor qualification and management in compliance with GMP and GDP, assists with audits, manages lifecycle materials, and ensures quality assessments and discrepancies are addressed. They coordinate with stakeholders, lead initiatives, and facilitate regulatory inspections to ensure compliance and quality standards are met.
Summary Generated by Built In

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 rich in diversity. 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.

Position: Supplier Quality ManagerLocation: Devens, MA.

Key Responsibilities:

  • Oversees the qualification and management of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) vendors. This includes identifying and assessing new vendors, developing and revising Quality Agreements, and maintaining the Approved Vendor List.

  • Act as a support team member during external audits, providing assistance under the supervision of the lead auditor as needed.

  • Manage the lifecycle starting materials used for the manufacture of drug substances/products, which involves material qualification, maintainance, reduced testing, and direct dispensing.

  • Conduct quality assessment of supplier change notifications and ensure actions are driven to completion utilizing change management programs.

  • Handle discrepancy reporting, deviations and Corrective and Preventive Actions (CAPA) related to nonconforming materials or services provided by vendors.

  • Perform quality reviews and approvals for functional area documents, including Standard Operation Procedures (SOPs), technical documents, reports, agreements, qualifications, and various forms.

  • Establishes and implement processes to ensure quality oversight of on-site service vendors, collaborating closely with Facilities & Engineering and QA Operations.

  • Assist in the preparation for and facilitation of regulatory inspections and audits as needed.

  • Coordinate / lead meetings with site stakeholders, other network sites and external partners to execute of vendor and material management programs, including discussions, negotiations, and dispute resolution.   

  • Lead the team in cross-functional meetings and initiatives concerning supplier and material activities.

Qualifications & Experience:

  • 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 biotech bulk and finished product manufacturing is highly preferred.

  • Comprehensive knowledge of cGMP regulations and guidelines in the US and EU.

  • Familiarity with Quality Risk Management principles is valuable.

  • Proficient understanding of electronic Quality Management Systems (QMS), including platforms 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.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

#LI-Onsite

BMSBL

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 an inclusive culture, promoting diversity 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 a diverse 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.

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Top Skills

Good Distribution Practices (Gdp)
Good Manufacturing Practices (Gmp)
Quality Agreements
Quality Management Systems (Qms)
Trackwise
Veeva/Infinity
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Lawrence Township, NJ
40,384 Employees
On-site Workplace

What We Do

At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome.

Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients.

Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do.

Similar Jobs

Takeda Logo Takeda

Business Operations Manager

Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Hybrid
Boston, MA, USA
50000 Employees
133K-209K Annually

Klaviyo Logo Klaviyo

Senior Manager, Business Operations

Consumer Web • eCommerce • Marketing Tech • Retail • Software • Analytics • Generative AI
Hybrid
Boston, MA, USA
2000 Employees
156K-234K Annually

DraftKings Logo DraftKings

Director, PDO

Digital Media • Gaming • Information Technology • Software • Sports • Esports • Big Data Analytics
Hybrid
Boston, MA, USA
5300 Employees

Klaviyo Logo Klaviyo

Office Coordinator

Consumer Web • eCommerce • Marketing Tech • Retail • Software • Analytics • Generative AI
Boston, MA, USA
2000 Employees

Similar Companies Hiring

Zealthy Thumbnail
Telehealth • Social Impact • Pharmaceutical • Healthtech
New York City, NY
13 Employees
Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
46000 Employees
Stepful Thumbnail
Software • Healthtech • Edtech • Artificial Intelligence
New York, New York
60 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account