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15.10.2021

Senior Specialist (Audit - Apheresis)

  • Field, Switzerland
  • Festanstellung 100%

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Senior Specialist (Audit - Apheresis)

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.

Remote position to support audits - up to 50% travel required

Cell Therapy is at the epicenter of personalized medicine, and this exciting opportunity gives the Senior Specialist (Audit) an opportunity to support the innovative and growing expansion of CAR-T therapies into European markets, for clinical and commercial purposes. 

The Senior Specialist (Audit) will support this objective through the auditing of apheresis collection centers, the sites where a patient’s blood is withdrawn, packaged, and shipped according to specified procedures.  This is a critical role within the Global Apheresis Compliance team that requires someone with demonstrated experience conducting audits in a regulated environment, familiarity with blood and tissue-related regulations such as ATMPs, JACIE, and/or familiarity with apheresis operations. 

Additionally, the Specialist will be able to contribute towards an annual risk assessment exercise, proposing and implementing audit process improvements, developing quarterly and annual metrics, and may have the opportunity to cross-train to support GMP/GDP audits related to other CAR-T vendors such as material suppliers, manufacturing organizations, analytical labs, and more. 

In this role, you will be responsible for (but not limited to):

  • Contacting, coordinating, and scheduling an audit with the proper contacts at each Apheresis Collection center, including assembling the proper audit team, and determining travel logistics as needed
  • Completing and distributing an Audit Agenda, and Pre-Audit Document Request form to initiate pre-audit document review
  • Scheduling audit with the audited entities, according to audit schedule
  • Leading preparation meetings with internal stakeholders
  • Conducting audit at the apheresis site to ensure compliance to applicable regulations
  • Writing the audit report within provided timelines, and issuing reports along with Audit Findings Response Plans and/or Audit Closure Memos
  • Assessing responses to audit observations and report all related metrics associated with each audit
  • In collaboration with management, lead the grading of observations and the identification of observation and effectiveness check requirements, ensuring that differences in opinion are resolved
  • Reviewing and track all observation responses and observation actions that result from an audit, determine if observation responses are complete and if not, negotiate with observation owner(s)
  • Meeting with the business, audit team and SMEs to refine the risk assessment, ensuring all risks are identified, and finalizing the audit agenda
  • Ensuring that the audit owner and potential observation owners are identified; lead resolution of issues regarding identification of owners
  • Resolving schedule issues and escalate issues where appropriate
  • Contributing towards quarterly and annual audit program metrics
  • Proposing and implement improvements to the apheresis audit program

Your Profile:

  • BS/BA degree with substantial experience at a pharmaceutical or biotechnology under a GMP/GTP environment, or significant experience directly related to apheresis-operations within a hospital or similarly regulated industry
  • Must have an understanding of GMP and GTP regulations
  • Strong communication skills (verbal and written) in English
  • Must be able to work independently and productively from a remote position 
  • Experience working in a cross-functional discipline within a personalized medicine setting
  • Understanding or prior working knowledge within a personalized medicine, autologous/cell therapy discipline
  • Commitment to self-development and ability to stay abreast of internal and external requirements
  • Ability to travel up to 50% of the time, and at times, with limited notice

Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.

Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.

Arbeitsort:

Field, Switzerland