Senior Manager, Principal Specialist, Quality Risk Management

Position Title:

Sr. Manager - Principal Specialist/Engineer, Quality Risk Management

Division:

CTDO Quality Assurance Org

Direct Reports:

N/A

Location:

Summit West, S-12

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

PURPOSE AND SCOPE OF POSITION:

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Experience and thorough understanding of risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices.

• Proven experience working as a detailed oriented team player with effective planning, organization and execution skills.
• Experience with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc.).
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
• Able to manage multiple priorities.
• Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
• Ability to make independent and objective decisions, and to work with minimal supervision.
• Must be able to interact with multidiscipline departments and Cell Therapy Development & Operations (CTDO) sites.
• Must possess an independent mindset and tenacity.
• Must be skilled in planning and organizing, coaching others, decision-making and building relationships.
• Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
• Ability to work effectively across functional groups and teams to ensure requirements are met.
• Excellent verbal and communication skills.

• Bachelor’s degree in Science required; advanced degree preferred.
• Minimum 7 years’ experience of Quality Risk Management in a cGMP/FDA regulated environment such as manufacturing/QC or QA.
• Experience in CAR T or Biologics preferred.
• Professional certification in Quality Risk Management preferred.
• Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

The primary responsibilities of the Principal Specialist Quality Risk Management are to evaluate and implement a plan to mitigate process and/or product risks and to support cross functional departments on risk identification, root cause analysis and investigative measures.

• Contribute to the writing, coordination, review, approval and maintenance of the S12 Risk Management Standard Operating Procedures (SOPs) and associated documentation.
• Develop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.
• Evaluate and report key performance metrics, analyze data and lead improvement initiatives.
• Facilitate planning, execution and completion of risk assessments by providing direction, and guidance to cross functional teams.
• Ensure product risk management documentation/files are maintained, with good documentation practices and in compliance with S-12 Quality System.
• Partner with other risk management stakeholders, including Validation, Manufacturing, Quality Control, Patient Scheduling, Facilities, Warehouse and Safety.
• Drive continuous improvement for effective risk management and to address recurring issues identified throughout S-12.
• Track and verify appropriate corrective actions have been implemented, documented and align with source event.
• Maintain S12 Quality Risk Catalog, Risk Register Registry and track the status of risk mitigation actions through to completion.
• Schedule and facilitate S-12 risk assessment activities to identify risk areas and implement risk mitigation measures to support manufacturing, compliance and business continuity.
• Conduct risk reviews and escalate findings, as appropriate, to S12 Risk Management Leadership with resolution and recommendations.
• Represent the Risk Management unit at various project meetings and provide quality input in the resolution of quality-related issues.
• Work independently and perform with a high degree of accuracy.
• Apply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines and documentation practices.
• Proactively learn, develop and customize methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

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