Sr Manager
vor 6 Monaten
Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.
PURPOSE AND SCOPE OF POSITION:
The Senior Manager, Global QA Apheresis Compliance Team Lead is responsible for audits of Contract Service Providers, assessing compliance with regulatory and BMS requirements, to identify quality risks, assess severity and facilitate appropriate mitigations to ensure compliance and continuous improvement. This global position has responsibility for managing audit related activities of Apheresis Collection Sites supporting CAR-T Patient Operations, worldwide.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Experience within the Cellular Therapy environment.
- Experience with Clinical and Commercial Manufacturing of drug products.
- Leadership skills: ensuring effective allocation of resources by means of target and priority setting as well as motivation communication
- Interpersonal skills: excellent communicator, coaches and inspires people to achieve team goals, delivers training to achieve and keep state of the art knowledge, establishes a collaborative environment, and manage well interfaces with other units.
- Detail-oriented with expertise in problem solving and solid decision-making abilities.
- Ability to work in a fast-paced environment.
Education and Experience:
Relevant college or university degree required; advanced degree preferred.
- Minimum of 10 years of relevant GMP/GDP/GTP pharmaceutical/biotechnology industry experience, including at least 5 years of Compliance related auditing experience.
- Experience with pharmaceutical products including sterile, biologic and/or cell therapy products.
- Must have expert GMP/GTP, Quality, and risk management knowledge.
- Must be able to critically interpret problems and effectively communicate in a productive manner to management, the group, and the broader organization with clarity and a high level of brevity and accuracy.
- Must be able to recognize and group technical/scientific attributes in potential situations or issues and drive science-based decisions across the function.
- Must have expert authorship in technical documents. Must be able to critically interpret results and generate technical conclusions consistent with Quality risk principles.
- Must have expert authorship in audit reports, investigations, quality agreements, and risk assessments. Must be able to critically interpret results and determine the desirability of new or additional content for GMP/GTP policies and standards, etc.
- Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation. Must possess authenticity.
- Knowledge of pharmaceutical products including biologic and/or cell therapy products.
**DUTIES AND RESPONSIBILITIES**:
- General Responsibilities
- Leads an international team of auditors actively managing departmental operations
- Develops department training plan, trains, and develops team members
- Manages contracting, training and activities of contract auditors
- Develops, implements and maintains department Standards, SOPS, and Guidance documents
- Stays abreast of current global regulations; updates SOPs and Guidance documents as required
- Leads or participates in multi-disciplinary project teams as required
- Will participate in, lead and/or observe audits as required to meet audit schedules, assure consistent department performance, and assess junior staff
- Contribute and support the on-time completion of annual and quarterly risk assessment of auditable entities
- Coordinate, schedule and ensure the on-time completion of audits part of the onboarding program res execution of all required audits
- Participates in the development, qualification and maintenance of electronic solutions supporting the audit program
- Supports change control related to vendor status and maintenance of approved vendor lists or equivalent
- May include N domestic and/or international travel Apheresis Audit Program Management
- Develops, implements, and maintains department SOPs and Work Practices for the audit of apheresis collection sites globally against current regulatory standards
- Acts as the point of contact with Patient Operations for the scheduling and execution of
apheresis audits
- Directs audit related activities with contract audit companies that audit on BMS's behalf.
- Includes assurance of training to BMS
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