Senior Manager, GCP/PV Quality Assurance
Gilead
IT
4 gg fa

Job Description

Senior Manager, Good Clinical Practice & Pharmacovigilance Practice Auditor

Organization Description

About Kite Pharma, A GILEAD Company

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-

term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.

Kite Europe is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs.

We’re building a state-of-the art manufacturing site in the Netherlands (Amsterdam-Hoofddorp).

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Department Description

As a Senior Manager GCP / PV you’ll be joining a newly formed team at Kite in Amsterdam (The Netherlands), where employees of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity.

You’ll be reporting to the Director R&D Quality and Compliance.

Your Responsibilities and Challenges

You’ll have a hands-on role in which you’ll be responsible for performing quality assurance activities to ensure that the Kite’s GCP and Pharmacovigilance activities are conducted in accordance with GCP / PV guidelines, applicable regulations and company policies and procedures.

You’ll be part of an exciting journey where the specific, different technology is still in development in the industry.

In this role, you won’t have any direct reports.

Your Responsibilities, among others, will be :

  • Lead or participate in GCP and Pharmacovigilance audits (Internal, Clinical Sites, Third Party, Vendor, Systems) to ensure compliance with GCP / PV guidelines, applicable regulations and company policies and procedures company SOPs
  • Lead or participate in Systems Audits including development of audit plans and tools, managing audit conduct, and reporting the results
  • Obtain audit responses from company functional areas or vendors and evaluates proposed CAPAs for adequacy if implemented successfully in accordance with company SOPs
  • Provide interpretation and guidance for internal and external customers on GCP / PV related regulations / guidelines (FDA, ICH, EU, etc.
  • and company procedures and policies

  • Contribute quality compliance data for metrical analysis; Provide updates at daily and weekly meetings
  • Support the development and refinement of the Quality Systems by leading or participating in SOP authorship or review teams
  • Contribute to the development of continuous quality process improvements
  • Other duties as assigned
  • Key requirements and experiences :

    Education

  • Bachelor’s degree or advanced degree in a scientific or related discipline
  • Knowledge / experience

  • 10 years of experience in the biotechnology or pharmaceutical industry, with at least 8 years in a GCP / PV compliance / quality role;
  • depending on the candidate’s relevant knowledge / experience acquired, there could be some flexibility regarding the years of experience.

  • Experience in performing or participating in GCP and PV audits
  • Experience with biologics with cellular therapies a plus
  • Experience in Compliance assessments, including EU Risk Management Plans
  • Proficient in MS Word, Excel, Power Point and other applications
  • Personal skills

  • Ability to balance multiple priorities in a fast paced environment while delivering a timely and high quality end work product
  • Excellent interpersonal, verbal and written communication skills ; working language English is a must, additional linguistic skill is a plus
  • Self-directed and able to work independently with minimal direction in a fast-paced small company environment, applying judgment with limited information or guidance
  • Willingness to travel; this position may require up to 30% travel
  • If you feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us.

    Apply now!

    Only candidates in possession of a valid EU work permit will be considered.

    Recruitment agencies : We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.

    Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-

    term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.

    Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow KitePharma on Twitter at www.twitter.com / kitepharma.

    For Current Kite Pharma Employees and Contractors :

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

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