Bristol-Myers Squibb
Director, GDM Process Excellence
Bristol-Myers Squibb, Princeton, New Jersey, us, 08543
Director, GDM Process ExcellenceApply
Locations:
Princeton - NJ - US, Madison - Giralda - NJ - US
Time Type:
Full time
Posted On:
Posted 27 Days Ago
Job Requisition ID:
R1584434
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.
The Director, GDM Process Excellence is a leadership role accountable for the maintenance of a robust Quality Management System (QMS) covering GDM business processes and quality events. The role will serve as Global Process Owner for GDM.
This is a full-time NJ, USA office-based position with flexibility to work from home up to 50% of the time.
Responsibilities:
Set the strategic vision to ensure efficient, effective, compliant working practices. Establish appropriate structures and processes to execute the strategy.
Lead GDM Subject Matter Experts (SMEs) and relevant stakeholder functions in the development and maintenance of global processes, procedures, and training materials.
Provide guidance and direction to GDM SMEs to ensure the procedure development process, content, and format comply with Global GxP requirements, BMS Global Quality Standards, and BMS’ QMS principles of integrated, patient-centric, and risk-based decision-making.
Collaborate with other Process Leads and SMEs to drive optimal execution of process across BMS and external partners.
Define process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms including both product/clinical trial quality and process effectiveness aspects.
Lead efforts to scope, plan, and implement process improvements such as process, procedure, systems, and training material changes; and use of appropriate change management and communication principles.
Serve as the central point of contact for GDM regarding GxP audits and inspections, coordinating with GDM Leaders and SMEs on the preparation and subsequent follow-up activities.
Provide guidance to ensure effective corrective and preventative action plans are defined for any GDM related audit and inspection findings and actions plans are tracked to completion.
Provide training to GDM Leaders and staff regarding procedure development and CAPA definition to promote quality.
Collaborate with R&D Learning to define and maintain role-based procedure training curricula.
Ensure adaptive management of a global team through the effective deployment of resources and streamlined processes.
Provide ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empower and hold staff to high quality performance and delivery.
Engage and energize employees through communication of goals, priorities, and other business critical information as well as focus on employee value proposition, development, and retention activities.
Develop and promote a workplace culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability.
Lead the resolution of complex issues related to the function and those that cross functions. Direct team members as needed to drive to resolution and keep leadership informed of progress/results.
Develop strong and productive working relationships with key stakeholders throughout BMS, demonstrate the ability to think strategically across R&D, and effectively influence peers and senior management.
Represent the company with key external organizations as part of any committee or industry group relating to GxP/QMS, data quality & integrity activities.
Degree Requirements:
Bachelor's degree required with an advanced degree preferred.
Experience Requirements:
At least 10 years of relevant industry experience in concentrated disciplines of R&D, Operations, Validation, and/or Quality preferred.
Key Competency Requirements:
Expert understanding of the drug development process and clinical trial execution.
Expert knowledge of industry trends and emerging technologies supporting clinical trial data acquisition and management.
Expert knowledge of GCP/ICH guidelines.
Proven track record of resolving complex issues and driving significant initiatives to completion.
Ability to lead and make decisions with an enterprise mindset, considering what is best for the company and for patients.
Proven track record in functioning within a global matrix organization exerting positive, effective influence to achieve quality outputs.
Demonstrated change agility in anticipating and leading others through change and ambiguity.
Demonstrated partnership across various collaborative and industry forums.
Demonstrated people management experience.
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,” 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 ProtocolBMS 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.
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.
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.
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Locations:
Princeton - NJ - US, Madison - Giralda - NJ - US
Time Type:
Full time
Posted On:
Posted 27 Days Ago
Job Requisition ID:
R1584434
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.
The Director, GDM Process Excellence is a leadership role accountable for the maintenance of a robust Quality Management System (QMS) covering GDM business processes and quality events. The role will serve as Global Process Owner for GDM.
This is a full-time NJ, USA office-based position with flexibility to work from home up to 50% of the time.
Responsibilities:
Set the strategic vision to ensure efficient, effective, compliant working practices. Establish appropriate structures and processes to execute the strategy.
Lead GDM Subject Matter Experts (SMEs) and relevant stakeholder functions in the development and maintenance of global processes, procedures, and training materials.
Provide guidance and direction to GDM SMEs to ensure the procedure development process, content, and format comply with Global GxP requirements, BMS Global Quality Standards, and BMS’ QMS principles of integrated, patient-centric, and risk-based decision-making.
Collaborate with other Process Leads and SMEs to drive optimal execution of process across BMS and external partners.
Define process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms including both product/clinical trial quality and process effectiveness aspects.
Lead efforts to scope, plan, and implement process improvements such as process, procedure, systems, and training material changes; and use of appropriate change management and communication principles.
Serve as the central point of contact for GDM regarding GxP audits and inspections, coordinating with GDM Leaders and SMEs on the preparation and subsequent follow-up activities.
Provide guidance to ensure effective corrective and preventative action plans are defined for any GDM related audit and inspection findings and actions plans are tracked to completion.
Provide training to GDM Leaders and staff regarding procedure development and CAPA definition to promote quality.
Collaborate with R&D Learning to define and maintain role-based procedure training curricula.
Ensure adaptive management of a global team through the effective deployment of resources and streamlined processes.
Provide ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empower and hold staff to high quality performance and delivery.
Engage and energize employees through communication of goals, priorities, and other business critical information as well as focus on employee value proposition, development, and retention activities.
Develop and promote a workplace culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability.
Lead the resolution of complex issues related to the function and those that cross functions. Direct team members as needed to drive to resolution and keep leadership informed of progress/results.
Develop strong and productive working relationships with key stakeholders throughout BMS, demonstrate the ability to think strategically across R&D, and effectively influence peers and senior management.
Represent the company with key external organizations as part of any committee or industry group relating to GxP/QMS, data quality & integrity activities.
Degree Requirements:
Bachelor's degree required with an advanced degree preferred.
Experience Requirements:
At least 10 years of relevant industry experience in concentrated disciplines of R&D, Operations, Validation, and/or Quality preferred.
Key Competency Requirements:
Expert understanding of the drug development process and clinical trial execution.
Expert knowledge of industry trends and emerging technologies supporting clinical trial data acquisition and management.
Expert knowledge of GCP/ICH guidelines.
Proven track record of resolving complex issues and driving significant initiatives to completion.
Ability to lead and make decisions with an enterprise mindset, considering what is best for the company and for patients.
Proven track record in functioning within a global matrix organization exerting positive, effective influence to achieve quality outputs.
Demonstrated change agility in anticipating and leading others through change and ambiguity.
Demonstrated partnership across various collaborative and industry forums.
Demonstrated people management experience.
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,” 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 ProtocolBMS 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.
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.
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.
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