Senior Manager, Operational Risk Management

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Position Summary The Senior Manager, Operational Risk Management will be responsible to enhance QRM capabilities for key Quality Risk Management (QRM) processes within the GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP) across the Product Lifecycle. This key role will support the business to drive QRM process optimization, integration, adoption and continuous improvement through procedural writing, capability building, meeting management, digital enhancement and trend analysis of QRM data. Main responsibility will be design and execution of QRM certification program, co-chair oversight and best practice sharing meetings. Supports External Engagement and Regulatory Intelligence Activities. Works cross-functionally to develop QRM performance improvement initiatives throughout the organization by interacting and working with many great teams and leaders across the BMS network. Will provide together with the Associate Director Risk Management and Director Quality Risk Management strategic and tactical oversight.
This position will report into the Senior Director, Risk Management.
Key Responsibilities Proactively identify needs for QRM specific capability building: this entails supporting the development and management of a structured approach to continue and enhance building the Quality Risk Management (QRM) skills and abilities within BMS.
Provide guidance and support enterprise wide for enhancing risk management capabilities and QRM process elements in partnership with the Director Quality Risk Management.
Provide QRM content and expertise in different training modalities enterprise-wide through various formats and channels, ensuring accessibility for employees throughout the entire company. Modalities may include online courses, workshops, webinars, printed materials, interactive sessions and a well developed up to date repository.
Train and support business on risk management tools and methodology, offering guidance on policies, SOPs, and internal control frameworks.
Support QRM program: process design, deployment, maintenance, monitoring and improvement of QRM procedures and methodologies (tools) via collaboration and by authoring and/or reviewing procedures.
Support GXP Phase Appropriate QRM Content in Processes, procedures and learning material in collaboration with the business by tailored approaches adhering to the specific regulatory requirements and standards applicable to each phase.
Build formal Certification Program for employees to achieve certain standards or levels of proficiency in QRM including designing the certification criteria, managing assessments or evaluations, and awarding certifications to qualified individuals and support the program.
Co-Chair the Facilitator Best Practice Sharing Forum: a platform where facilitators involved in the QRM processes can share best practices, insights, and experiences to enhance skills and ensure consistency.
Provide leadership, coaching, and training for PLs and COP and facilitators including both the technical processes and the behaviors necessary to optimize QRM process execution.
Provide PEARL trainings and follow-up with identified teams and prepare reports regularly or on demand such as for Quality and Governance Councils.
Collaborates on digital QRM with key stakeholders. Support the testing and roll out of IT systems supporting QRM processes and data analytics.
Support process monitoring/adoption and GxP risk profiles through data collection, analysis, trending and reporting of QRM dashboards in collaboration with I&T.
Stakeholder Partnering and Engagement: Support together with the Associate Director Risk Management the partnership with teams across BMS for stakeholder-oriented incorporation/improvement of QRM principles and appropriate risk-based approaches into the business processes of the Quality Management System enterprise-wide.
Support the Director, External Engagement Insights Integrator in leading PEARL process and teams and by this risk identification and continuous improvement of external engagement and regulatory intelligence.
Support the Director External Engagement in driving BMS external involvement in key focused areas with highest impact to the company, its products and patients, through building external networks with industry and regulators, and risk-based and continuous improvement mindset.
Foster a culture of risk awareness, risk informed decision making and proactive risk management throughout the organization and by this increase QRM maturity.
Support QRM Communication for different meetings and purposes.
Business support: Support process monitoring through data collection, analysis, trending and reporting of QRM dashboards in collaboration with I&T. Provide guidance on QRM methodologies and can support the business by conducting facilitation of risk assessments.
Stay updated with industry best practices and regulatory requirements related to QRM, regulatory trends and regulatory intelligence, communicate within BMS and adapt internal processes effectively.
Collaborate with internal and external stakeholders to ensure alignment and compliance with QRM processes.
Monitor and evaluate the effectiveness of QRM initiatives, and recommend improvements as needed. Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
Qualifications & Experience Bachelor's degree in pharmaceutical sciences, engineering, biology, or other related discipline or equivalent combination of education and experience. Master's degree a plus. R&D experience a plus.
A minimum of 8 years of biopharmaceutical/pharmaceutical industry experience with at least 2 years in risk management leadership role.
Expertise in GMP compliance, Quality System and global GMP regulations with different QRM methodologies in GXP areas (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP).
Must have strong knowledge and experience with Quality Risk Management, strong demonstrated experience in conducting risk assessments.
Experience in capability building in general and in Quality Risk Management.
Experience in authoring and reviewing various documentations such as SOPs, WIS, presentations and training material.
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.
Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks effectively.
Enterprise mindset to think and act across functions and divisions.
Ability to work in a fast-paced and dynamic environment, managing multiple priorities simultaneously.
Strong leadership and project management skills, with the ability to lead cross-functional teams.
Expert-level knowledge and experience using data to drive understanding, decisions, and recommendations; Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels.
Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
Travel: Ability to travel 10-20% as needed.
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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.
Compensation Overview Devens - MA - US: $149,010 - $180,569
New Brunswick - NJ - US: $139,260 - $168,755
Princeton - NJ - US: $139,260 - $168,755
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 https://careers.bms.com/life-at-bms/.
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 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.
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/
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Company: Bristol-Myers Squibb
Req Number: R1594881
Updated: 2025-10-01 04:15:07.920 UTC
Location: Dublin-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.

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