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Senior Manager, Operational Risk Management

Senior Manager, Operational Risk Management

Bristol Myers SquibbNew Brunswick, NJ, US
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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.

Position Summary

The Senior Manager, Operational Risk Management will be responsible for enhancing 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.
  • Provide guidance and support enterprise-wide for enhancing risk management capabilities and QRM process elements.
  • Provide QRM content and expertise in different training modalities enterprise-wide.
  • Train and support business on risk management tools and methodology.
  • Support QRM program : process design, deployment, maintenance, monitoring, and improvement.
  • Support GXP Phase Appropriate QRM Content in Processes, procedures, and learning material.
  • Build formal Certification Program for employees to achieve certain standards or levels of proficiency in QRM.
  • Co-chair the Facilitator Best Practice Sharing Forum.
  • Provide leadership, coaching, and training for PLs and COP and facilitators.
  • Provide PEARL trainings and follow-up with identified teams and prepare reports.
  • Collaborate on digital QRM with key stakeholders.
  • Support process monitoring / adoption and GxP risk profiles through data collection, analysis, trending, and reporting.
  • Stakeholder Partnering and Engagement.
  • Support the Director, External Engagement Insights Integrator in leading PEARL process and teams.
  • Support the Director External Engagement in driving BMS external involvement.
  • Foster a culture of risk awareness, risk informed decision making, and proactive risk management.
  • Support QRM Communication for different meetings and purposes.
  • Business support : Support process monitoring through data collection, analysis, trending, and reporting.
  • Stay updated with industry best practices and regulatory requirements related to QRM.
  • 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.

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.
  • 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.
  • Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks effectively.
  • Enterprise mindset to be able 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.
  • 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 / adjustment

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    Operational Risk Manager • New Brunswick, NJ, US

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