At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Senior Manager, Inspection Management is responsible for supporting the Summit West Cell Therapy operation by preparing for, organizing, and leading inspections conducted by global Health Authorities. The incumbent serves as a member of the Inspection Readiness team supporting operational strategies and direction for site inspections. In addition, the Senior Manager Inspection Management coordinates responses to regulatory inspections; shares best practices and lessons learned following inspections; and works with department leaders to build an inspection readiness capability across the organization. The Senior Manager Inspection Management is also responsible for managing and motivating team members, building trust and cultivating a collaborative environment.
As a member of the Quality Assurance Organization, this position is working closely with the Cell Therapy Senior Leadership Team 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:
Provide leadership and oversight during Health Authority inspections.
Establish and maintain inspection management processes and procedures.
Develop inspection readiness training for subject matter experts, inspection support team, and all site personnel.
Work collaboratively with other sites to ensure consistency in inspection management processes.
Create employee development plans, and oversight of functional area to assure adequate staffing.
Promote the spirit of proactive, continuous quality improvement.
Lead the development and execution of the Site Inspection Readiness Plan that proactively prepares S12 Cell Therapy for Health Authority inspections.
Initiate the Gap Assessment and/or Mock inspection in support of the PLI readiness.
Maintain and coordinate inspection readiness content, including building and maintaining a content repository, to ensure quick access to materials for inspections.
Build and implement tools to improve inspection readiness at the site.
Identify trends in recent regulatory inspections and translate this to recommendations to improve site readiness.
Collaborate with Regulatory Compliance team to close gaps and improve inspection readiness capabilities.
Responsible for defining the Inspection Support team and process that will support all regulatory inspections.
Lead practices and recommend improvements to ensure S12 is inspection-ready at all times.
Manage Health Authority inspection preparation activities and provide leadership and oversight during inspections.
Coordinate pre-inspection documents including streamlining information needed from other groups at the site, and above-site (Global) level.
Responsible for responding to regulatory inquiries during inspections and ensure timely and accurate responses.
Improve and implement efficient methodologies and tools for the handling of regulatory inspections.
Maintain a Corrective and Preventive Action (CAPA) system for findings/observations due to regulatory inspections, including developing reports for trend analysis.
Experience leading and facilitating Health Authority inspections.
Strong leader that has developed high performing, independent and capable teams.
Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders.
Experience managing change in dynamic, fast-paced environment.
Strong/deep knowledge in industry practices and regulations applicable to biologics/cell therapy manufacturing, and across multiple Health Authorities (e.g. FDA, EMA, etc.).
Self-starter with demonstrated ability to work independently and in a team environment.
Appreciation of sense of urgency and prioritization of multiple projects and timelines.
Must be skilled in planning and organizing, conflict management, training and coaching others, talent selection, and resource allocation.
Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
Must possess an independent mindset and tenacity.
Excellent verbal and written communication skills.
Education and Experience:
Bachelor’s degree in Science required; advanced degree preferred.
Experience in CAR T/Cell Therapy or Biologics preferred.
Thorough understanding of cGMPs and global regulations.
Experience with leading FDA and other agency regulatory inspections is essential.
Experience with Pre-License Inspection (PLI) preferred.
Equivalent combination of education and experience acceptable.