Overview
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 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.
Responsibilities
Proactively identify needs for QRM specific capability building: developing and managing 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 (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: 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: creating and maintaining a platform for facilitators to share best practices, insights, and experiences to enhance facilitator skills and ensure consistency in QRM practices.
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 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 partnership with teams across BMS for stakeholder-oriented incorporation/improvement of QRM principles into enterprise-wide processes.
Support the Director External Engagement Insights Integrator in leading PEARL processes and teams for risk identification and continuous improvement of external engagement and regulatory intelligence.
Support the Director External Engagement in driving external involvement in key areas with highest impact through building external networks with industry and regulators, and a risk-based continuous improvement mindset.
Foster a culture of risk awareness, risk-informed decision making and proactive risk management to increase QRM maturity.
Support QRM communications for different meetings and purposes.
Business support: Monitor process through data collection, analysis, trending and reporting of QRM dashboards in collaboration with I&T; provide guidance on QRM methodologies and facilitate risk assessments.
Stay updated with industry best practices and regulatory requirements related to QRM, regulatory trends and regulatory intelligence, communicating within BMS and adapting internal processes accordingly.
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; support site and function teams during regulatory inspections or audits, including 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 a risk management leadership role.
Expertise in GMP compliance, Quality Systems and global GMP regulations with different QRM methodologies in GXP areas (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP).
Strong knowledge and experience with Quality Risk Management and conducting risk assessments.
Experience in capability building in general and in Quality Risk Management.
Experience in authoring and reviewing documentation such as SOPs, WIs, presentations and training materials.
Demonstrated ability to work in a matrixed organization with diverse teams and to influence across areas not under direct control; effective communication of goals and objectives.
Excellent analytical and problem-solving skills to identify and mitigate risks.
Enterprise mindset to think and act across functions and divisions.
Ability to work in a fast-paced environment, managing multiple priorities; strong leadership and project management skills to lead cross-functional teams.
Expert-level use of data to drive understanding, decisions, and recommendations; excellent communication and interpersonal skills.
Demonstrates innovation, flexibility, open-mindedness, and adaptability in a rapidly changing environment.
Strong communication, collaboration, negotiation, problem solving and interpersonal skills; proven track record of working across regulator/industry boundaries to drive positive impact for patients.
Travel: Ability to travel 10-20% as needed.
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