The Senior Manager GMP Audits Cell Therapy is responsible for managing the Summit (Building S12) Cell Therapy Internal Audit (Self-Inspection) Program in accordance with BMS policies, standards, procedures and global cGMPs. In this role, the incumbent will be responsible for the formulation of appropriate audit programs for S12, assigning and directing staffing resources to complete the audit plan as scheduled, and supporting the Quality Management System to ensure compliance and minimize risk in a regulated Pharmaceutical environment. The Senior Manager GMP Audits Cell Therapy 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 S12 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:
Responsible for providing direction and oversight of the site internal audit program.
Establish and maintain audit processes and procedures for GMP audit function.
Effectively establishes and manages the Internal Audit schedule.
Identify new risks that may not be accounted for in the original audit plan and make any necessary adjustments to mitigate the site’s risk.
Responsible for developing a training program for auditor qualification.
Manage performance of audit team during audit engagements.
Work collaboratively with other sites to ensure consistency in auditing processes.
Create employee development plans, and oversight of functional area to assure adequate staffing.
Ensure processes and procedures associated with Internal Audits are properly implemented.
Develop risk-based audit planning focusing on patients, and adherence to all policies, procedures and regulations applicable to CAR T products.
Meet with area leads, audit team and/or SMEs to refine the scope and depth of the audit agenda.
Lead the execution and conduct of the audit.
Ensure that findings are identified, evidence is collected where possible, all potential critical findings are immediately identified, and audit expectations and next steps are identified.
Escalate potentially critical observations to the Site Quality Head.
Maintain a comprehensive system for recording all audit plans, findings, reports, and follow-up audits.
Provide critical review of internal audit findings and audit reports to ensure alignment with the Audit Plan and to ensure that Corrective/Preventive Action (CAPA) plans are adequate to address the findings.
Collaborate with stakeholders to ensure resolution of audit findings identified on-site.
Follow-up and track CAPA plan from Internal Audits through completion.
Support the site to prepare and execute Corporate audits and Health Authority inspections for multiple markets.
Responsible for effectively multi-tasking and managing priorities in a fast paced and changing environment.
Benchmark through industry associations to ensure processes and systems are consistent with industry best practices.
Perform gap assessments to identify process deficiencies, provide reports to document detailed findings and recommend potential solutions.
Develop, manage and report Quality Metrics for Internal Audits to monitor compliance.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Strong/deep knowledge of core auditing processes.
Experience leading and facilitating internal audits.
Detail-oriented with expert knowledge of cGMP regulations, as well as biologics/aseptic/cell therapy regulations, and ability to use judgement and this knowledge to determine appropriate quality systems compliance for site.
Strong leader that has developed high performing, independent and capable teams.
Ability to make independent and objective decisions, and to work with minimal supervision.
Must be able to interact with and influence multidiscipline departments and Cell Therapy Development & Operations (CTDO) sites.
Must be able to conceptualize broad impact of Quality systems on site or Quality initiatives and recognize broad Quality issues.
Must possess an independent mindset and tenacity.
Must be skilled in planning and organizing, conflict management, training and coaching others, talent selection, and resource allocation.
Requires minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with manager for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact team.
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 written communication skills.
Education and Experience:
Bachelor’s degree in Science required; advanced degree preferred.
7-10 years of relevant Quality Assurance work experience in the pharmaceutical Industry and a minimum of 3-5 years leading GMP internal and/or external audits required.
Strong Leadership/Managerial Skills required.
Experience in Cell Therapy/CAR T or Biologics preferred.
Certified Quality Auditor (e.g. ASQ) preferred.
Thorough understanding of cGMPs and global regulations.
Equivalent combination of education and experience acceptable.
Internal Number: R1535721
About Bristol Myers Squibb
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