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.
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PURPOSE AND SCOPE OF POSITION:
The Principal Specialist Quality Risk Management CAR T is responsible for supporting the S-12 Cell Therapy Quality Risk Management Program in accordance with BMS policies, standards, procedures and global cGMPs. The primary focus for this role is to facilitate the risk assessments, in order to identify risk areas and implement risk mitigation measures for S-12 operations, cGMP compliance and business continuity. Additionally, this role is responsible to maintain quality risk management program deliverables and facilitate complex cross-functional issue resolution by employing a methodical approach to root cause analysis and implementing appropriate corrective and preventive actions.
As a member of the Quality Assurance Organization, this position is working closely with the S-12 Quality Risk Management leadership and other company risk management stakeholders, to identify and provide solutions to cGMP related issues and escalate them as appropriate to ensure the site remains in a state of control.
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.
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.
Education and Experience: