Associate Director, R&D Quality
Gilead Sciences
Tokyo, Japan
4 日前

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home.

Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors :

Please log onto your Internal Career Site to apply for this job.

Job Description

Specific Responsibilities :

Essential Functions :

We are seeking an Associate Director to join R&D Quality Japan (which is a part of the global organization R&D Quality and Medical Governance headquartered in Foster City, USA).

This position is in Tokyo reporting to Senior Director. R&D Quality provides quality oversight on GCP, GVP and GPSP activities through effectively managing audit program, CAPAs and regulatory authority inspections.

We seek an individual with excellent team-player mindset to work cross functionally, a strong sense of ownership in areas of responsibility, and expert knowledge of the regulations governing drug development and post marketing activities.

Responsibilities (including but are not limited to) :

  • Serve as an expert and provide guidance on compliance regulations, standards and quality management systems related to GCP, GVP and GPSP for internal and external stakeholders, and foster a culture of quality with the stakeholders.
  • Under the guidance and support of senior management, lead PMDA inspections in close collaboration with global teams consisting of internal SMEs and SMEs of external organizations such as CROs and vendors.
  • You will chair inspection team meetings, coordinate and supervise preparation of pre-inspection materials, make SMEs ready for the inspection by holding functional area meetings to address potential issues, providing consultation and holding a mock-inspection etc.

    You will also chair the inspection and lead response management.

  • During any type of PMDA consultations, you will be responsible for interaction with PMDA in terms of inspection related matters.
  • Perform and / or coordinate various types of audits in GCP, GVP and GPSP in multiple therapeutic areas according to the annual audit plan, including investigator site audits, internal audits, vendor audits and partner audits.
  • Write audit reports accurately and concisely, or review audit reports written by other auditors. Evaluate responses from auditees to audit observations.

  • Establish relationship with contract auditors and manage all aspects of outsourcing audits to them including contract management, maintaining their training status on audit procedures up-to date, coordination for individual audits and oversight of audit activities they have performed.
  • Management of CAPAs deriving from R&D functions in the Japan affiliate and vendors in Japan.
  • Provide review on internal procedural documents pertaining to GCP, GVP and GPSP to make sure those are in line with the current regulatory requirements.
  • Performance and task management of employees and contractors may be required.
  • Maintain and promote productive working relationships with all stakeholders.
  • Perform other duties as assigned.
  • Knowledge, Experience & Skills :

    Essential : Desirable :

    Desirable : Qualifications

    Qualifications

  • Bachelor’s degree with 10+ years; Master’s degree with 8+ years; or PhD with 6+ years of R&D compliance experience.
  • Strong working knowledge of relevant regulations in drug development and post-marketing phase (GCP, GVP and GPSP).
  • Experience in performing or coordinating audits in GCP and / or GVP and / or GPSP.
  • Proven ability in leading or coordinating PMDA inspections.
  • Excellent interpersonal, verbal, and written communication skills in both Japanese and English in an international working environment.
  • Self-motivated and flexibility to accept temporary tasks outside of the job description
  • Proficient in Microsoft Office suite.
  • Ability to travel up to 20%
  • For Current Gilead Employees and Contractors :

    Please log onto your Internal Career Site to apply for this job.

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