Associate Director of Quality Risk Management (QRM) and Business Continuity Planning - Bristol Myers Squibb
Summit, 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 and Experience:
+ Bachelor's degree in a relevant scientific or technical field. Advanced degree preferred.
+ 8+ years of experience within the pharmaceutical or biotechnology industry
+ 4+ + years of experience in Quality Risk Management (QRM). within the pharmaceutical or biotechnology industry.
+ Experience in Business Continuity Management (BCM) desired
+ Strong knowledge of GxP regulations and guidelines.
+ Proven experience in driving process optimization, integration, and continuous improvement.
+ Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks effectively.
+ Strong leadership and project management skills, with the ability to lead cross-functional teams.
+ Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels.
+ Ability to work in a fast-paced and dynamic environment, managing multiple priorities simultaneously.
+ Strong attention to detail and a commitment to ensuring the safety, quality, and continuity of operations.
+ Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
+ Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
Responsibilities :
+ Champion process development, deployment, maintenance, monitoring and improvement of assigned QRM procedures and methodologies (tools) and BCP procedures.
+ Work with Quality Systems and Compliance partners to lead the stakeholder-oriented incorporation/improvement of QRM principles and appropriate risk-based approaches into the business processes of the Quality Management System enterprise-wide.
+ Provide guidance and support to teams in implementing risk management strategies and business continuity plans.
+ Collaborate closely with cross-functional teams to proactively identify, assess, communicate and mitigate risks associated with our products, processes, and facilities.
+ Stay updated with industry best practices and regulatory requirements related to QRM and BCP.
+ Foster a culture of risk awareness, risk informed decision making and proactive risk management throughout the organization and by this increase QRM maturity.
+ Collaborate with internal and external stakeholders to ensure alignment and compliance with QRM and BCP processes.
+ Drive process monitoring/adoption and GxP risk profiles through data collection, analysis, trending and reporting of QRM dashboards, and following up on non-compliances, risk trends, and continuous improvement.
+ Monitor and evaluate the effectiveness of QRM and BCP initiatives, and recommend improvements as needed.
+ Prepare and present reports on QRM and BCP activities, trends, and performance metrics to senior management.
+ Work effectively across the GxP Quality Management Systems network, engaging with broader Process Owner network and functional/site SMEs in order meet project milestones, and continuously improvement process adoption and enhancements.
+ Participate/lead regulatory surveillance and Pharma Industry networking/benchmarking initiatives with peers internally and externally to ensure awareness of current regulations/guidance that impact QRM processes and identify/execute procedural enhancements as required.
+ Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
+ Lead/support QRM training/certification development & deployment as per QRM training strategy
+ Support/lead QRM Community of Practices (CoPs) including sharing best practices, training/coaching and regular communication of QRM strategies/risk dashboards and process improvements.
+ Serve as the liaison between the Global Quality Unit and the BCP teams during a crisis management situation.
+ Support GPS, R&D, and IT Business Units, together with Site BCP owners, with test exercises to check and improve BCP and crisis management processes; improvements should be made to global GxP BCP processes as applicable.
+ Define the process for managing major disruptions to the GxP business including how to respond in a Risk Based manner (incorporating QRM principles, tools and processes into the response)
+ Continually improve BMS response to GxP BCP after undergoing a crisis management situation
+ Accountable for the effective and efficient execution of the BCP process by the Site BCP owners as well as ensure full compliance with all internal and external regulatory requirements.
+ Provide leadership, coaching, and training for PLs and COP including both the technical processes and the behaviors necessary to optimize process execution.
+ Support the testing and roll out of IT systems supporting QRM processes and data analytics.
+ Assist with the preparation and reporting for Enterprise Risk Management.
+ Travel: This position requires up to 15% of travel.
#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: R1582110
Updated: 2024-06-21 03:31:01.824 UTC
Location: Cruiserath-IE
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 and Experience:
+ Bachelor's degree in a relevant scientific or technical field. Advanced degree preferred.
+ 8+ years of experience within the pharmaceutical or biotechnology industry
+ 4+ + years of experience in Quality Risk Management (QRM). within the pharmaceutical or biotechnology industry.
+ Experience in Business Continuity Management (BCM) desired
+ Strong knowledge of GxP regulations and guidelines.
+ Proven experience in driving process optimization, integration, and continuous improvement.
+ Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks effectively.
+ Strong leadership and project management skills, with the ability to lead cross-functional teams.
+ Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels.
+ Ability to work in a fast-paced and dynamic environment, managing multiple priorities simultaneously.
+ Strong attention to detail and a commitment to ensuring the safety, quality, and continuity of operations.
+ Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
+ Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
Responsibilities :
+ Champion process development, deployment, maintenance, monitoring and improvement of assigned QRM procedures and methodologies (tools) and BCP procedures.
+ Work with Quality Systems and Compliance partners to lead the stakeholder-oriented incorporation/improvement of QRM principles and appropriate risk-based approaches into the business processes of the Quality Management System enterprise-wide.
+ Provide guidance and support to teams in implementing risk management strategies and business continuity plans.
+ Collaborate closely with cross-functional teams to proactively identify, assess, communicate and mitigate risks associated with our products, processes, and facilities.
+ Stay updated with industry best practices and regulatory requirements related to QRM and BCP.
+ Foster a culture of risk awareness, risk informed decision making and proactive risk management throughout the organization and by this increase QRM maturity.
+ Collaborate with internal and external stakeholders to ensure alignment and compliance with QRM and BCP processes.
+ Drive process monitoring/adoption and GxP risk profiles through data collection, analysis, trending and reporting of QRM dashboards, and following up on non-compliances, risk trends, and continuous improvement.
+ Monitor and evaluate the effectiveness of QRM and BCP initiatives, and recommend improvements as needed.
+ Prepare and present reports on QRM and BCP activities, trends, and performance metrics to senior management.
+ Work effectively across the GxP Quality Management Systems network, engaging with broader Process Owner network and functional/site SMEs in order meet project milestones, and continuously improvement process adoption and enhancements.
+ Participate/lead regulatory surveillance and Pharma Industry networking/benchmarking initiatives with peers internally and externally to ensure awareness of current regulations/guidance that impact QRM processes and identify/execute procedural enhancements as required.
+ Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
+ Lead/support QRM training/certification development & deployment as per QRM training strategy
+ Support/lead QRM Community of Practices (CoPs) including sharing best practices, training/coaching and regular communication of QRM strategies/risk dashboards and process improvements.
+ Serve as the liaison between the Global Quality Unit and the BCP teams during a crisis management situation.
+ Support GPS, R&D, and IT Business Units, together with Site BCP owners, with test exercises to check and improve BCP and crisis management processes; improvements should be made to global GxP BCP processes as applicable.
+ Define the process for managing major disruptions to the GxP business including how to respond in a Risk Based manner (incorporating QRM principles, tools and processes into the response)
+ Continually improve BMS response to GxP BCP after undergoing a crisis management situation
+ Accountable for the effective and efficient execution of the BCP process by the Site BCP owners as well as ensure full compliance with all internal and external regulatory requirements.
+ Provide leadership, coaching, and training for PLs and COP including both the technical processes and the behaviors necessary to optimize process execution.
+ Support the testing and roll out of IT systems supporting QRM processes and data analytics.
+ Assist with the preparation and reporting for Enterprise Risk Management.
+ Travel: This position requires up to 15% of travel.
#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: R1582110
Updated: 2024-06-21 03:31:01.824 UTC
Location: Cruiserath-IE
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