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Position Summary
The Senior Manager, Operational Risk Management will 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 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 responsibilities include design and execution of a 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 with teams and leaders across the BMS network. Provides strategic and tactical oversight together with the Associate Director Risk Management and Director Quality Risk Management.
This position reports to the Senior Director, Risk Management.
Key Responsibilities
* Proactively identify needs for QRM capability building and help develop a structured approach to enhance QRM skills 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.
* Deliver QRM content in various training modalities (online courses, workshops, webinars, printed materials, interactive sessions, and a well-maintained repository) to ensure accessibility across the company.
* Train and support the business on risk management tools and methodology, advising on policies, SOPs, and internal control frameworks.
* Support QRM program design, deployment, maintenance, monitoring and improvement of QRM procedures and methodologies (tools) through collaboration and by authoring/reviewing procedures.
* Support GXP Phase Appropriate QRM content in processes, procedures and learning materials in collaboration with the business, aligning with regulatory requirements for each phase.
* Build a formal Certification Program for employees to achieve specified QRM proficiency levels, including designing criteria, managing assessments, awarding certifications, and supporting the program.
* Co-Chair the Facilitator Best Practice Sharing Forum to enable facilitators to share best practices and ensure consistency in QRM practices across the organization.
* Provide leadership, coaching, and training for PLs and COPs and facilitators, including technical processes and behaviors to optimise QRM execution.
* Deliver PEARL trainings and report regularly to Quality and Governance Councils.
* Collaborate on digital QRM with stakeholders; test and roll out 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 with I&T.
* Engage with stakeholders to incorporate QRM principles into enterprise quality management processes.
* Support External Engagement insights and risk-based regulatory intelligence initiatives.
* Drive external engagement through building networks with industry and regulators; foster a risk-based and continuous improvement mindset.
* Foster a culture of risk awareness and proactive risk management to increase QRM maturity; support QRM communications for various meetings.
* Provide business support through data-driven monitoring, trend analysis and risk assessments facilitation; stay updated on industry best practices and regulatory requirements related to QRM.
* Collaborate across internal and external stakeholders to ensure alignment with QRM processes and monitor effectiveness of QRM initiatives; support regulatory inspections or audits as needed.
Qualifications & Experience
* Bachelor’s degree in pharmaceutical sciences, engineering, biology, or related discipline; master’s degree a plus; R&D experience a plus.
* Minimum of 8 years in biopharmaceutical/pharmaceutical industry with at least 2 years in a risk management leadership role.
* Expertise in GMP compliance, Quality System and global GMP regulations with QRM methodologies in GXP areas (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP).
* Strong knowledge and experience with Quality Risk Management and risk assessments; capability building in QRM.
* Experience authoring and reviewing SOPs, WIs, presentations and training materials.
* Proven ability to work in a matrixed organization, influence non-direct reports, and communicate objectives across diverse teams.
* Excellent analytical and problem-solving skills with the ability to mitigate risks effectively; enterprise-minded and cross-functional thinking.
* Ability to work in a fast-paced environment with multiple priorities; strong leadership and project management skills.
* Expert-level data-driven decision making and communication skills; demonstrated collaboration with regulators/industry to benefit patients.
* Travel: 10-20% as needed.
Compensation and Benefits
For locations in Devens, MA; New Brunswick, NJ; Princeton, NJ: salary ranges are listed in the job posting. Additional incentive cash and stock opportunities may be available based on eligibility. Final compensation is based on experience.
Eligibility for benefits varies by job and location. Benefits may include medical, pharmacy, dental, vision, 401(k), life insurance, disability, travel protection, paid holidays and vacation, parental and caregiver leave, adoption and surrogacy support, tuition reimbursement, and more. For details, visit careeers.bms.com/life-at-bms/.
On-site Protocol and Equal Opportunity
BMS occupancy and work model details: site-essential, site-by-design, field-based and remote-by-design roles. Site-essential require 100% onsite; site-by-design may be hybrid with at least 50% onsite; field-based/remote-by-design require travel and onsite presence as needed.
BMS is committed to an accessible recruitment process. Reasonable accommodations are available; contact adastaffingsupport@bms.com for inquiries. See careers.bms.com/eeo-accessibility for our Equal Employment Opportunity statement.
BMS supports vaccination for Covid-19 as a precaution for employee and community well-being. Qualified applicants with arrest and conviction records will be considered under applicable laws. For Los Angeles County residents, additional information is available at careers.bms.com/california-residents/.
Any data processed in connection with role applications will be treated in accordance with data privacy policies and regulations.
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