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Director, quality risk management

Dublin
Bristol Myers Squibb
Risk manager
Posted: 28 June
Offer description

Working with UsChallenging.
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 SummaryThe Director, Quality Risk Management will drive consistent Global Leadership on Quality Risk Management (QRM), the Risk Management Framework, Risk Posture considerations and provide support for key QRM processes within the GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP) across the Product Lifecycle.
Accountable to drive QRM process optimization, integration, adoption and continuous improvement through capability building, key stakeholder engagement, digital enhancement, trend analysis of QRM data and guidance on authoring QRM procedures.
Works cross-functionally to develop performance improvement initiatives throughout the organization by interacting and working with many great teams and leaders across the BMS network.This position will report into the Senior Director, Risk Management.Key Responsibilities:Provide strategic and tactical leadership for establishing and maintaining robust QRM programs across the BMS QMS Level 1 and 2 processes and sub-processes, end-to-end product lifecycle and across all BMS in alignment with relevant governmental regulations and guidelines.Drive process design, simplification, deployment, maintenance, monitoring and improvement of QRM procedures and methodologies (tools).
Provide oversight for the management of all changes being planned and executed in these processes.In partnership with the Senior Director, Risk Management, champion the E2E, across product lifecycle QRM Framework and strategic roadmap.Develop and Drive enhancement on digital QRM mapping.
Lead execution digital roadmap.Develop Risk Tolerance statements, risk acceptance statements and guiding principles for BMS QRM related risk posture.Lead Risk identification and risk communication/reporting for governance meetings, such as Quality management reviews and Enterprise Risk Management and support managing emerging risks to support business objectives.Lead and support to teams in implementing risk management capabilities and process elementsProvide guidance and coaching for the Risk Management Team.Lead the QRM training framework and certification program design & oversee deployment.Foster a culture of risk awareness, risk informed decision making and proactive risk management throughout the organization and by this enhance QRM maturity.Stakeholder Partnering and Engagement: Lead 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.Co-chair with the Senior Director, Risk Management, QRM specific governance and oversight forums.Business support: Drive process monitoring/adoption and GxP risk profiles through overseeing data collection, analysis, trending and reporting of QRM dashboards in collaboration with I&T .Stay updated with industry best practices and regulatory requirements related to QRM communicate within BMS and adapt internal processes effectively.Works across regulator/industry boundaries to become a QRM industry leader, find common solutions, and drive positive impact and benefits for patients.Collaborate with internal and external stakeholders to ensure alignment and compliance with QRM processes.Provide direction and critical input for setting metrics and monitoring and evaluating 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.Oversee the process design for managing major disruptions to the GxP business including how to respond in a Risk Based manner (incorporating QRM principles, tools and processes into the response)Provide leadership, coaching, and training for members of the QRM Community of Practice and other QRM practitioners including both the technical processes and the behaviors necessary to optimize process execution.Support the testing and roll out of IT systems supporting QRM processes and data analytics.Qualifications & Experience:Master's degree in pharmaceutical sciences, engineering, biology, or other related discipline or equivalent combination of education and experience.A minimum of 15 years of biopharmaceutical/pharmaceutical industry experience with at least 3 years in risk management leadership position.Expertise in GMP compliance, Quality System and global GMP regulationsMust have strong knowledge and expert understanding using different QRM tools for the different GXP areas (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP).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.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.Demonstrated influential leadership expertise and experience with senior level interactions.Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks effectivelyEnterprise 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.Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlines.Travel: Ability to travel 10-25% as neededGPS_2025 GQ_2025The starting compensation for this job is a range from $187,700 to $227,400, plus incentive cash and stock opportunities (based on eligibility).The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.Final, individual compensation will be decided based on demonstrated experience.
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.

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