Supplier Quality Senior Specialist - Bristol Myers Squibb
Devens, MA
About the Job
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 .
The Senior Specialist of Supplier Quality is responsible for the oversight of the GMP/GDP Vendor and Material Management programs at the Devens Biologics site. This includes Quality management of vendor qualification, material qualification, change management and supplier non-conformance reporting / resolution.
Key Responsibilities:
+ Responsible for the qualification and management of GMP/GDP vendors, including identification/assessment of new vendors, creation / revision of Quality agreements and maintenance of the Approved Vendor List.
+ May participate in external audits.
+ Responsible for the lifecycle management of starting materials used for the manufacture of drug substance/product.
+ Performs Quality assessment of supplier change notifications and drives actions through to completion using change management programs.
+ Assists in discrepancy reporting, deviations and CAPA associated with nonconforming materials or services provided by vendors.
+ Establishes and executes a process to ensure Quality oversight of on-site service vendors.
Role 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 with directly relevant experience in a regulated environment, biopharmaceutical environment or similar, is required.
+ Practical knowledge of US and EU cGMP regulations and guidance and ISO standards.
+ Knowledge of electronic systems including any of the following: SAP, Veeva, and Syncade.
+ Past experience of successful participation on, and sometimes leading, a team where combined contribution, collaboration, and results were expected.
+ Previous work experience where attention to detail and personally accountability is critical to success.
+ Excellent written and oral communication skills are required.
+ Individual will interact with contacts within the following organizations: Quality Assurance, Network Quality, Quality Control, Material Science & Technology, Strategic Sourcing, Site Procurement, External Suppliers and on as required basis, Supply Chain, Manufacturing Operations and Manufacturing Support.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
Company: Bristol-Myers Squibb
Req Number: R1586419
Updated: 2024-10-18 05:10:55.214 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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 .
The Senior Specialist of Supplier Quality is responsible for the oversight of the GMP/GDP Vendor and Material Management programs at the Devens Biologics site. This includes Quality management of vendor qualification, material qualification, change management and supplier non-conformance reporting / resolution.
Key Responsibilities:
+ Responsible for the qualification and management of GMP/GDP vendors, including identification/assessment of new vendors, creation / revision of Quality agreements and maintenance of the Approved Vendor List.
+ May participate in external audits.
+ Responsible for the lifecycle management of starting materials used for the manufacture of drug substance/product.
+ Performs Quality assessment of supplier change notifications and drives actions through to completion using change management programs.
+ Assists in discrepancy reporting, deviations and CAPA associated with nonconforming materials or services provided by vendors.
+ Establishes and executes a process to ensure Quality oversight of on-site service vendors.
Role 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 with directly relevant experience in a regulated environment, biopharmaceutical environment or similar, is required.
+ Practical knowledge of US and EU cGMP regulations and guidance and ISO standards.
+ Knowledge of electronic systems including any of the following: SAP, Veeva, and Syncade.
+ Past experience of successful participation on, and sometimes leading, a team where combined contribution, collaboration, and results were expected.
+ Previous work experience where attention to detail and personally accountability is critical to success.
+ Excellent written and oral communication skills are required.
+ Individual will interact with contacts within the following organizations: Quality Assurance, Network Quality, Quality Control, Material Science & Technology, Strategic Sourcing, Site Procurement, External Suppliers and on as required basis, Supply Chain, Manufacturing Operations and Manufacturing Support.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
Company: Bristol-Myers Squibb
Req Number: R1586419
Updated: 2024-10-18 05:10:55.214 UTC
Location: Devens-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb
