Associate Director, Quality Risk Specialist
Bristol Myers Squibb
Princeton, NJ
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. 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 . The Associate Director, RBQM - HOCT, ICN will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. Key Responsibilities:
Madison - Giralda - NJ - US: $163,850 - $198,543
New Brunswick - NJ - US: $163,850 - $198,543
Princeton - NJ - US: $163,850 - $198,543 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. 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 a supportive culture, promoting global participation 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 an 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 [email protected] . 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: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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. 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 . The Associate Director, RBQM - HOCT, ICN will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. Key Responsibilities:
- Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
- As part of the upstream protocol authoring process, partner with Drug Development, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
- During trial conduct, provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. This will involve partnering with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from audits, inspections, internal quality events, significant issues, and external intelligence to inform QbD.
- At the study level, conduct quality assurance spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
- Assist the business in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
- Support for cause, critical and/or complex quality issues as well as serious breaches for the TA, where deemed necessary.
- Provide quality and compliance consultation to clinical trials teams throughout study lifecycle.
- Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.
- Establish strong partnership with business stakeholders.
- Partner with the study teams to ensure effective management of significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.
- Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.
- Provide R&D Quality expertise, critical thinking, deliver training and share best practices and lessons learned into future trials.
- Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.
- Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.
- External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.
- Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.
- Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level.
- Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline.
- Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.
- Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or crosslines.
- May influence the external environment through interactions with regulators, trade associations, or professional societies.
- Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.
- B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
- Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
- Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
- Very experienced in Risk Based Quality Management principles.
- In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management
- Understanding of BMS's therapeutic areas - HOCT and ICN.
- Extensive experience in regulatory inspection preparation, management, and related follow-up.
- Demonstrated analytical and conceptual capability-including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data.
- Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
- Communication Skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.
- Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
- Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies.
- Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.
- Fosters a culture in which people continually work to improve services, and work processes.
Madison - Giralda - NJ - US: $163,850 - $198,543
New Brunswick - NJ - US: $163,850 - $198,543
Princeton - NJ - US: $163,850 - $198,543 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. 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 a supportive culture, promoting global participation 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 an 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 [email protected] . 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: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Posted 2025-10-29
Recommended Jobs
Associate Director, US Medical Affairs Oncology Solid Tumors
Daiichi Sankyo, Inc.
New Jersey
Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address dive…
View Details
Posted 2025-09-24
Medical Technologist
95 Old Short Hills Road
West Orange, NJ
Job Title: Medical Technologist Location: SBC Corporation Department Name: Lab MMC Req #: 0000209864 Status: Hourly Shift: Night Pay Range: $36.35 - $48.29 per hour Pay Transparen…
View Details
Posted 2025-08-23
Junior Event Coordinator
Made Acquisitions Inc
New Brunswick, NJ
Junior Event Coordinator Location New Brunswick, NJ : Benefits: Bonus based on performance Company parties Competitive salary Opportunity for advancement Training & development Juni…
View Details
Posted 2025-11-01
Technical Sales Representative
Grupdev
Mount Laurel, NJ
Job Description Job Description Company: Grupdev Job Title: Technical Sales Representative - Product Development and DevOps Location: Remote Job Description: We are seeking a highly s…
View Details
Posted 2025-08-18
Automotive Technician
LEGACY TOWING LLC
Brick, NJ
Job Description Job Description We are currently seeking an Automotive Technician to become an integral part of our team! You will diagnose, adjust, repair, and overhaul automotive vehicles. …
View Details
Posted 2025-08-18
Cashier/ Counter help
Terrace Bagels & Cafe
Freehold, NJ
Job Description Job Description We are seeking motivated individuals to work the front end of our bagel store and cafe. Job responsibilities include: - Taking orders -Bagging bagels - Ha…
View Details
Posted 2025-09-06
Registered Nurse (RN) Medical Surgical Unit IV (4E) Full Time Night
355 Grand Street
Jersey City, NJ
Job Title: RN Location: Jersey City Medical Center Department Name: Medical Surgical Unit IV Req #: 0000219232 Status: Hourly Shift: Night Pay Range: $46.47 - $64.93 per hour Pay …
View Details
Posted 2025-10-14
Teens: Research Study Participant Video Project Irvington
Recrewt
Irvington, NJ
About the session. Were inviting teens ages 1319 to join a fun, inperson research session focused on everyday movement and comfort on camera. The session lasts approximately 90 minutes and is held a…
View Details
Posted 2025-10-03
Auto Technician Mechanic
Toyota Universe
Little Falls, NJ
Job Description Job Description SIGN ON BONUS $5000 *WILL HIRE TODAY*....Busy highway Toyota dealership is in need of automotive technicians to start immediately. We are currently looking for al…
View Details
Posted 2025-09-19