Manager, Supplier Changes - Bristol Myers Squibb
New Brunswick, NJ
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 .
Qualifications & Experience
+ Bachelor's degree in science, or a related field.
+ 5+ years of experience in a pharmaceutical/ biopharmaceutical/Advanced Therapeutic Modality Products (ATMP) environment including previous QA experience - e.g., QA compliance role, Supplier Quality oversight and managing teams. ATMP experience a plus.
+ Strong knowledge of quality management systems, change control processes, deviation processes and regulatory requirements.
+ Experience in conducting risk assessments and implementing risk mitigation strategies.
+ Excellent understanding of supplier management principles and practices.
+ Strong analytical and problem-solving skills, with the ability to analyze complex data and make informed decisions.
+ Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and suppliers.
+ Proven ability to drive change, foster a culture of continuous improvement, and deliver results.
+ Ability to work in a fast-paced environment.
+ Certifications such as Certified Quality Manager (CQM) or Certified Supplier Quality Professional (CSQP) are a plus.
+ Proficient in using quality management software and tools. Veeva Quality Suite experience a plus.
Key Responsibilities
Supplier Change Management:
+ Develop, implement, and maintain a robust supplier change management process to effectively evaluate, approve, and implement supplier changes.
+ Collaborate with cross-functional teams, including Procurement, Material Sciences, Engineering and Regulatory Affairs, to assess the impact of supplier changes on product quality, safety, and regulatory compliance.
+ Ensure that all supplier changes are properly documented, reviewed, and approved in accordance with established procedures.
+ Perform other duties in support of BMS Vendor & Material Mgmt. Quality System development and maintenance as assigned.
+ Other responsibilities as assigned.
Risk Assessment:
+ Conduct thorough risk assessments for supplier changes to identify potential risks and their impact on product quality, safety, and regulatory compliance.
+ Utilize risk assessment tools and methodologies to evaluate the severity, probability, and detectability of identified risks.
+ Collaborate with cross-functional teams to develop risk mitigation strategies and contingency plans for high-risk supplier changes.
Change Control Processes:
+ Establish and maintain effective change control processes for supplier changes, ensuring that all changes are properly evaluated, documented, and implemented.
+ Review and approve change requests, ensuring that they are complete, accurate, and aligned with quality standards and regulatory requirements.
+ Monitor and track the progress of supplier change initiatives, ensuring that they are executed within defined timelines and budgets.
Supplier Performance Monitoring:
+ Collaborate with the Supplier Quality team to establish and maintain a comprehensive supplier performance monitoring system for assessing the quality and reliability of suppliers.
+ Identify opportunities for supplier improvement and collaborate with suppliers to implement corrective and preventive actions.
SOP Development and Revision:
+ Collaborate with subject matter experts and cross-functional teams to develop new SOPs or revise existing ones.
+ Conduct thorough research and gather information to ensure accuracy and completeness of SOP content.
+ Write clear, concise, and well-structured SOPs that align with QMS requirements, regulatory requirements, and company standards.
+ Ensure SOPs are easily understandable and user-friendly for employees at all levels.
+ Collaborate with training and development teams to ensure effective training programs are in place for SOP implementation.
+ Assist in the development of training materials and job aids to support SOP understanding and adherence.
+ Communicate SOP updates and changes to relevant stakeholders and ensure proper implementation.
Compliance and Regulatory Requirements:
+ Ensure that all supplier changes comply with applicable regulatory requirements, industry standards, and internal quality management systems.
+ Stay updated on relevant regulations and industry best practices related to supplier changes and incorporate them into the change management process.
+ Collaborate with Regulatory Affairs and Quality Assurance teams to ensure that all necessary regulatory submissions and notifications are completed for supplier changes.
Continuous Improvement:
+ Drive continuous improvement initiatives related to supplier change management processes, tools, and systems.
+ Analyze data and metrics related to supplier changes to identify trends, areas for improvement, and opportunities to enhance efficiency and effectiveness.
+ Collaborate with cross-functional teams to implement process improvements and best practices for managing supplier changes.
Other Responsibilities:
+ Support Health Authority inspections and audits of BMS sites/functions, act as QA representative (SME) for functional area relevant topics.
+ Lead/Participate as QA representative to internal work streams, projects and improvement initiatives.
+ Other responsibilities, as assigned.
#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 adastaffingsupport@bms.com . 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.
Company: Bristol-Myers Squibb
Req Number: R1583036
Updated: 2024-06-28 03:18:57.342 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 .
Qualifications & Experience
+ Bachelor's degree in science, or a related field.
+ 5+ years of experience in a pharmaceutical/ biopharmaceutical/Advanced Therapeutic Modality Products (ATMP) environment including previous QA experience - e.g., QA compliance role, Supplier Quality oversight and managing teams. ATMP experience a plus.
+ Strong knowledge of quality management systems, change control processes, deviation processes and regulatory requirements.
+ Experience in conducting risk assessments and implementing risk mitigation strategies.
+ Excellent understanding of supplier management principles and practices.
+ Strong analytical and problem-solving skills, with the ability to analyze complex data and make informed decisions.
+ Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and suppliers.
+ Proven ability to drive change, foster a culture of continuous improvement, and deliver results.
+ Ability to work in a fast-paced environment.
+ Certifications such as Certified Quality Manager (CQM) or Certified Supplier Quality Professional (CSQP) are a plus.
+ Proficient in using quality management software and tools. Veeva Quality Suite experience a plus.
Key Responsibilities
Supplier Change Management:
+ Develop, implement, and maintain a robust supplier change management process to effectively evaluate, approve, and implement supplier changes.
+ Collaborate with cross-functional teams, including Procurement, Material Sciences, Engineering and Regulatory Affairs, to assess the impact of supplier changes on product quality, safety, and regulatory compliance.
+ Ensure that all supplier changes are properly documented, reviewed, and approved in accordance with established procedures.
+ Perform other duties in support of BMS Vendor & Material Mgmt. Quality System development and maintenance as assigned.
+ Other responsibilities as assigned.
Risk Assessment:
+ Conduct thorough risk assessments for supplier changes to identify potential risks and their impact on product quality, safety, and regulatory compliance.
+ Utilize risk assessment tools and methodologies to evaluate the severity, probability, and detectability of identified risks.
+ Collaborate with cross-functional teams to develop risk mitigation strategies and contingency plans for high-risk supplier changes.
Change Control Processes:
+ Establish and maintain effective change control processes for supplier changes, ensuring that all changes are properly evaluated, documented, and implemented.
+ Review and approve change requests, ensuring that they are complete, accurate, and aligned with quality standards and regulatory requirements.
+ Monitor and track the progress of supplier change initiatives, ensuring that they are executed within defined timelines and budgets.
Supplier Performance Monitoring:
+ Collaborate with the Supplier Quality team to establish and maintain a comprehensive supplier performance monitoring system for assessing the quality and reliability of suppliers.
+ Identify opportunities for supplier improvement and collaborate with suppliers to implement corrective and preventive actions.
SOP Development and Revision:
+ Collaborate with subject matter experts and cross-functional teams to develop new SOPs or revise existing ones.
+ Conduct thorough research and gather information to ensure accuracy and completeness of SOP content.
+ Write clear, concise, and well-structured SOPs that align with QMS requirements, regulatory requirements, and company standards.
+ Ensure SOPs are easily understandable and user-friendly for employees at all levels.
+ Collaborate with training and development teams to ensure effective training programs are in place for SOP implementation.
+ Assist in the development of training materials and job aids to support SOP understanding and adherence.
+ Communicate SOP updates and changes to relevant stakeholders and ensure proper implementation.
Compliance and Regulatory Requirements:
+ Ensure that all supplier changes comply with applicable regulatory requirements, industry standards, and internal quality management systems.
+ Stay updated on relevant regulations and industry best practices related to supplier changes and incorporate them into the change management process.
+ Collaborate with Regulatory Affairs and Quality Assurance teams to ensure that all necessary regulatory submissions and notifications are completed for supplier changes.
Continuous Improvement:
+ Drive continuous improvement initiatives related to supplier change management processes, tools, and systems.
+ Analyze data and metrics related to supplier changes to identify trends, areas for improvement, and opportunities to enhance efficiency and effectiveness.
+ Collaborate with cross-functional teams to implement process improvements and best practices for managing supplier changes.
Other Responsibilities:
+ Support Health Authority inspections and audits of BMS sites/functions, act as QA representative (SME) for functional area relevant topics.
+ Lead/Participate as QA representative to internal work streams, projects and improvement initiatives.
+ Other responsibilities, as assigned.
#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 adastaffingsupport@bms.com . 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.
Company: Bristol-Myers Squibb
Req Number: R1583036
Updated: 2024-06-28 03:18:57.342 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