Senior Specialist, Supplier Quality and Audits
Working with UsChallenging.
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, Supplier Quality and Audits is responsible for the oversight of the GMP/GDP Quality Agreements between BMS and external partners, including suppliers, distribution centers and service providers for the BMS Devens site.
This includes management, execution, resolution/delivery of the writing, review, approval of the agreements and the activities detailed below.
Duties & Responsibilities Manage the creation, revision of Quality Agreements (QAgs) and addendums to Quality Agreements between Client Sites and external partners (vendors, service providers, contract laboratories).
Plan and lead meetings with Client sites, stakeholders, and external partners to review and discuss QAg requirements.
Discuss, negotiate, and find resolution on comments I feedback on QAgs.
Coordinate feedback and update the QAgs based on the agreed discussion with stakeholders and external partners.
May participate in external audits as support team and under supervision of lead auditor.
Participates on the weekly discussion for Supplier Change Notifications for impact to supplier audits/Quality Agreements.
Supports management of the GMP/GDP Sharepoint for audit status.
i.
e.
, enter audit status and manage audit exception forms.
Performs quality review for area documents including QAgs initiated by other sites, audit reports, and Forms.
Represent team on cross-site meetings and initiatives related to supplier activities, new suppliers, etc.
Knowledge & Skill 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.
Must have excellent communication skills Candidate must have experience in quality systems including biotechnology manufacturing and quality control laboratories 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.
Work is largely performed in a modern office, may or may not have use of laboratory, and manufacturing facilities.
Personal Protective Equipment (PPE) will be required when inside of some portions of the facility.
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 CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Attention To Detail Auditing Biochemistry Biopharmaceuticals Biotechnology Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
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, Supplier Quality and Audits is responsible for the oversight of the GMP/GDP Quality Agreements between BMS and external partners, including suppliers, distribution centers and service providers for the BMS Devens site.
This includes management, execution, resolution/delivery of the writing, review, approval of the agreements and the activities detailed below.
Duties & Responsibilities Manage the creation, revision of Quality Agreements (QAgs) and addendums to Quality Agreements between Client Sites and external partners (vendors, service providers, contract laboratories).
Plan and lead meetings with Client sites, stakeholders, and external partners to review and discuss QAg requirements.
Discuss, negotiate, and find resolution on comments I feedback on QAgs.
Coordinate feedback and update the QAgs based on the agreed discussion with stakeholders and external partners.
May participate in external audits as support team and under supervision of lead auditor.
Participates on the weekly discussion for Supplier Change Notifications for impact to supplier audits/Quality Agreements.
Supports management of the GMP/GDP Sharepoint for audit status.
i.
e.
, enter audit status and manage audit exception forms.
Performs quality review for area documents including QAgs initiated by other sites, audit reports, and Forms.
Represent team on cross-site meetings and initiatives related to supplier activities, new suppliers, etc.
Knowledge & Skill 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.
Must have excellent communication skills Candidate must have experience in quality systems including biotechnology manufacturing and quality control laboratories 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.
Work is largely performed in a modern office, may or may not have use of laboratory, and manufacturing facilities.
Personal Protective Equipment (PPE) will be required when inside of some portions of the facility.
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 CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Attention To Detail Auditing Biochemistry Biopharmaceuticals Biotechnology Clinical Trials Estimated Salary: $20 to $28 per hour based on qualifications.
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