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Senior Specialist, Apheresis Audit - Germany (location Flexible), Boudry, Nebraska

CategoryQlty Assurance Methods
Job typeFull-Time

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.

Celgene (a wholly owned subsidiary of Bristol-Myers Squibb) is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skill sets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team.

Prerequisites (As Applicable)

Remote position to support audits throughout Germany - up to 70%-80% travel required

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

The Specialist will support this objective through the auditing of apheresis collection centers, the sites where a patient's blood is withdrawn, packaged, and shipped according to specified procedures.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 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 5+ years of experience at a pharmaceutical or biotechnology under a GMP/GTP environment, or 3+ years of healthcare 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 German & 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 70% of the time, and at times, with limited notice

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
EmployerBristol-Myers Squibb

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