Senior Manager, Operational Risk Management

Role Summary

The Senior Manager, Operational Risk Management will enhance Quality Risk Management (QRM) capabilities across GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP, and GVP) throughout the product lifecycle. The role drives QRM process optimization, integration, adoption and continuous improvement through procedural writing, capability building, meeting management, digital enhancement and trend analysis of QRM data. Primary responsibilities include the design and execution of a QRM certification program, co-chair oversight and best-practice sharing meetings, and support for external engagement and regulatory intelligence activities. The position reports to the Senior Director, Risk Management and works cross-functionally with teams across the BMS network to advance QRM maturity.

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 session 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 include 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 This element focuses on creating and maintaining a platform or forum where facilitators involved in the QRM processes can share best practices, insights, and experiences. The forum will serve as a collaborative space to enhance the skills of facilitators and to ensure consistency and quality in QRM practices across the organization.
• 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. Provides 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

• 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 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.

Education

• 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.

Additional Requirements

• Travel: Ability to travel 10-20% as needed.