Associate Director, Supplier Quality and Audits - 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 .
Position Summary
This position will support the external supplier audit program and serve as a Subject Matter Expert SME for Supplier qualification/Approval for the site. The incumbent will also serve as the Subject Matter Expert SME for the annual supplier Risk Assessment. The incumbent is involved in developing, modifying, and executing company policies that affect immediate operations and may have company-wide effect. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.
Key Responsibilities
+ Support the external supplier audit program as a team member and/or lead auditor. Serves as a Subject Matter Expert SME for Supplier qualification/Approval for the site
+ Ensure suppliers are qualified and conduct audits at defined frequencies as part of the supplier monitoring process.
+ Schedule and coordinate external supplier audits to support BMS global supply network.
+ Coordinate and manage the Audit Information Request Forms (AIRF) prior to conducting audits and gather inputs from impacted sites.
+ Supports as the Subject Matter Expert (SME) for the annual supplier Risk Assessment.
+ Author and maintain external audit schedule for the Devens Site. Ensure that suppliers have quality and production systems that meet applicable regulatory, cGMP and BMS global network requirements.
+ Evaluate finding responses, track responses and follow up on actions to closure.
+ Supports and participates in regulatory agency inspections and corporate audits.
+ Review, communicate and track audit findings across the network. Create, review, approve, and track corrective actions related to external audits.
+ Support the review, discussion and approval of Quality Agreements for external suppliers.
+ Participate on supplier business reviews, provide input for the topics that relate to supplier performance and audits outcome.
+ Support site activities that relate to the supplier change notification program and supplier complaint management program.
+ Support Vendor Qualification & Management Process with responsibility to ensure alignment with global policies and procedures.
+ Participates in and serves as Devens representative at Communities of Practice meetings.
+ This position requires up to 45 to 60% travel.
+ Work is largely performed in a modern office, laboratory and manufacturing facility where one must be aware of the presence of workplace hazards including pressurized liquids gases, steam and hazardous chemicals.
+ Use of Personal Protective Equipment (PPE) will be required in some portions of the facility.
Qualifications & Experience
+ Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent.
+ A minimum of 10 years' experience in biopharmaceutical quality,
+ Candidate must have auditing experience in auditing quality systems including biotechnology manufacturing and quality control laboratories. External audit certification (ASQ or otherwise) is highly desirable.
+ Knowledge of US and EU cGMP regulations and guidance.
+ Knowledge of Veeva and SAP is highly desirable.
+ Demonstrated leadership, interpersonal, communication, and motivation skills. Lead and guide junior auditors.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
If you come across a role that intrigues you but does not 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.
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: R1586448
Updated: 2024-11-08 05:10:33.645 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 .
Position Summary
This position will support the external supplier audit program and serve as a Subject Matter Expert SME for Supplier qualification/Approval for the site. The incumbent will also serve as the Subject Matter Expert SME for the annual supplier Risk Assessment. The incumbent is involved in developing, modifying, and executing company policies that affect immediate operations and may have company-wide effect. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.
Key Responsibilities
+ Support the external supplier audit program as a team member and/or lead auditor. Serves as a Subject Matter Expert SME for Supplier qualification/Approval for the site
+ Ensure suppliers are qualified and conduct audits at defined frequencies as part of the supplier monitoring process.
+ Schedule and coordinate external supplier audits to support BMS global supply network.
+ Coordinate and manage the Audit Information Request Forms (AIRF) prior to conducting audits and gather inputs from impacted sites.
+ Supports as the Subject Matter Expert (SME) for the annual supplier Risk Assessment.
+ Author and maintain external audit schedule for the Devens Site. Ensure that suppliers have quality and production systems that meet applicable regulatory, cGMP and BMS global network requirements.
+ Evaluate finding responses, track responses and follow up on actions to closure.
+ Supports and participates in regulatory agency inspections and corporate audits.
+ Review, communicate and track audit findings across the network. Create, review, approve, and track corrective actions related to external audits.
+ Support the review, discussion and approval of Quality Agreements for external suppliers.
+ Participate on supplier business reviews, provide input for the topics that relate to supplier performance and audits outcome.
+ Support site activities that relate to the supplier change notification program and supplier complaint management program.
+ Support Vendor Qualification & Management Process with responsibility to ensure alignment with global policies and procedures.
+ Participates in and serves as Devens representative at Communities of Practice meetings.
+ This position requires up to 45 to 60% travel.
+ Work is largely performed in a modern office, laboratory and manufacturing facility where one must be aware of the presence of workplace hazards including pressurized liquids gases, steam and hazardous chemicals.
+ Use of Personal Protective Equipment (PPE) will be required in some portions of the facility.
Qualifications & Experience
+ Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent.
+ A minimum of 10 years' experience in biopharmaceutical quality,
+ Candidate must have auditing experience in auditing quality systems including biotechnology manufacturing and quality control laboratories. External audit certification (ASQ or otherwise) is highly desirable.
+ Knowledge of US and EU cGMP regulations and guidance.
+ Knowledge of Veeva and SAP is highly desirable.
+ Demonstrated leadership, interpersonal, communication, and motivation skills. Lead and guide junior auditors.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
If you come across a role that intrigues you but does not 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.
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: R1586448
Updated: 2024-11-08 05:10:33.645 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
