Associate Director, Quality Product Lead - 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 .
Position Summary
The Associate Director (AD) Quality Product Lead (e.g., QPL, Quality Product Steward) for BMS is the responsible Quality representative for the lifecycle of commercial products/brands for the Biologics/Sterile Fill and Pharma business units. The QPL, Product Quality, will serve as an individual contributor and as the primary Global Quality representative for Commercial Brands on the Brand matrix Global Operations (GO) Team. This individual will be responsible for the Lifecycle management of commercial products as a core member of the GO team and will be responsible for measuring, monitoring, and developing action plans related to Quality Brand Health.
Key Responsibilities
As an Individual contributor:
+ Serve as the core Quality member of the global Operations team (GO) as the single point of contact for the commercial brand, responsible and accountable to the brand team for overall success against the strategic plan (lifecycle, footprint, markets, format, risks, business continuity).
+ Responsible for Commercial Brand Scorecards including continuous monitoring, data analysis, and reporting, leveraging the Quality systems and brand technical knowledge.
+ Define and recommend actions to improve brand Quality Health through Scorecards based off data and trending.
+ Approver of the global change management implementation plan, end-to-end preapproval inspection and launch readiness, responsibility for Right First Time (RFT) initial applications and post approval supplements for the late-stage early assets and Commercial brands. Responsible for compliance with approved licenses and approved market requirements.
+ Responsible to drive and facilitate Drug shortage notifications to management and lead the process for endorsement and approval of HA (Health Authority) notifications.
+ Evaluates impact of proposed post market changes on the end-to-end supply chain and develops, executes, and oversees change implementation strategies as the quality approver of global post marketing changes.
+ Responsible for on time delivery of the E2E APQR for represented corresponding brands and aligning on any conclusions and or actions.
+ Author Quality chapter for yearly brand strategy document for each commercial brand per schedule.
+ May be the Lead investigator for complex global investigations. Responsible for ensuring that any required HA notifications are approved within notification timelines.
Qualifications & Experience
+ #LI-HybridAt least 8 years of experience in the industry (Pharma, biotech, generics, over the counter, device, animal health, and/or vaccines) and demonstrated combined leadership in Quality, technical experience, in depth knowledge of cGXP and regulatory expectations, quality and compliance processes, operations and strategy in the biopharmaceutical industry.
+ The following would be considered advantageous but not required:
+ Similar prior role in other industries (listed earlier)
+ Lean six sigma, statistics, and/or business analytics certificate(s)
+ A high-level understanding of integrated drug development of biologics and/or pharma compounds.
+ Technical acumen in the areas of manufacturing and/or analytical testing of commercial brands
+ Matrix team experiences
+ Science minded, data driven and experience working in a matrix organization with Technical, Supply Chain, and/or Regulatory functional areas.
+ Act on decisions while balancing quality, speed and rigor.
+ Must be able to critically interpret problems, data and effectively communicate in an impactful manner to management, and the broader organization with clarity and a high level of brevity and accuracy.
+ Must possess a strategic perspective, leading vision and values, global supply acumen, and leadership disposition to ensure continued supply through the brand strategy.
+ Demonstrated Strategic and Analytical (structural/logical) thinking capability with project management skills, with the ability to focus on execution of decisions while balancing multiple priorities.
+ Adapts to changing work environments, work priorities and organizational needs.
+ Capable of interpretation of GMP regulations and guidelines.
+ Ensure sustainable compliance to corporate requirements as well as governmental regulations. Resolves problems of interpretation and administration of BMS policies and procedures.
+ Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).
#LI-Hybrid
_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.
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: R1579833
Updated: 2024-05-03 04:15:14.302 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
The Associate Director (AD) Quality Product Lead (e.g., QPL, Quality Product Steward) for BMS is the responsible Quality representative for the lifecycle of commercial products/brands for the Biologics/Sterile Fill and Pharma business units. The QPL, Product Quality, will serve as an individual contributor and as the primary Global Quality representative for Commercial Brands on the Brand matrix Global Operations (GO) Team. This individual will be responsible for the Lifecycle management of commercial products as a core member of the GO team and will be responsible for measuring, monitoring, and developing action plans related to Quality Brand Health.
Key Responsibilities
As an Individual contributor:
+ Serve as the core Quality member of the global Operations team (GO) as the single point of contact for the commercial brand, responsible and accountable to the brand team for overall success against the strategic plan (lifecycle, footprint, markets, format, risks, business continuity).
+ Responsible for Commercial Brand Scorecards including continuous monitoring, data analysis, and reporting, leveraging the Quality systems and brand technical knowledge.
+ Define and recommend actions to improve brand Quality Health through Scorecards based off data and trending.
+ Approver of the global change management implementation plan, end-to-end preapproval inspection and launch readiness, responsibility for Right First Time (RFT) initial applications and post approval supplements for the late-stage early assets and Commercial brands. Responsible for compliance with approved licenses and approved market requirements.
+ Responsible to drive and facilitate Drug shortage notifications to management and lead the process for endorsement and approval of HA (Health Authority) notifications.
+ Evaluates impact of proposed post market changes on the end-to-end supply chain and develops, executes, and oversees change implementation strategies as the quality approver of global post marketing changes.
+ Responsible for on time delivery of the E2E APQR for represented corresponding brands and aligning on any conclusions and or actions.
+ Author Quality chapter for yearly brand strategy document for each commercial brand per schedule.
+ May be the Lead investigator for complex global investigations. Responsible for ensuring that any required HA notifications are approved within notification timelines.
Qualifications & Experience
+ #LI-HybridAt least 8 years of experience in the industry (Pharma, biotech, generics, over the counter, device, animal health, and/or vaccines) and demonstrated combined leadership in Quality, technical experience, in depth knowledge of cGXP and regulatory expectations, quality and compliance processes, operations and strategy in the biopharmaceutical industry.
+ The following would be considered advantageous but not required:
+ Similar prior role in other industries (listed earlier)
+ Lean six sigma, statistics, and/or business analytics certificate(s)
+ A high-level understanding of integrated drug development of biologics and/or pharma compounds.
+ Technical acumen in the areas of manufacturing and/or analytical testing of commercial brands
+ Matrix team experiences
+ Science minded, data driven and experience working in a matrix organization with Technical, Supply Chain, and/or Regulatory functional areas.
+ Act on decisions while balancing quality, speed and rigor.
+ Must be able to critically interpret problems, data and effectively communicate in an impactful manner to management, and the broader organization with clarity and a high level of brevity and accuracy.
+ Must possess a strategic perspective, leading vision and values, global supply acumen, and leadership disposition to ensure continued supply through the brand strategy.
+ Demonstrated Strategic and Analytical (structural/logical) thinking capability with project management skills, with the ability to focus on execution of decisions while balancing multiple priorities.
+ Adapts to changing work environments, work priorities and organizational needs.
+ Capable of interpretation of GMP regulations and guidelines.
+ Ensure sustainable compliance to corporate requirements as well as governmental regulations. Resolves problems of interpretation and administration of BMS policies and procedures.
+ Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).
#LI-Hybrid
_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.
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: R1579833
Updated: 2024-05-03 04:15:14.302 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