BrightOwl Loader Loading

Director, Good Clinical Practice Amsterdam Netherlands,  

Job Score (company)

Posted on : 01 June 2017

Project Description

  • Our company 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. 
  • Our company  is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs. 
  •  You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.  
  • This individual will work cross functionally to develop our quality assurance systems and processes to meet all European GCP requirements. 
  • This role will be a hands-on resource reporting to the company quality head.


Responsibilities (include but are not limited to): 
Responsible for the company  Good Clinical Practice to:
  • Develop and implement GCP quality systems for company European Clinical Research that follow International Congress of Harmonization (ICH) guidance, Competent Authority regulations and other relevant guidance 
  • Develop and implement internal company GCP systems that are inspection ready by EMA in all applicable areas of Clinical research including Clinical, Medical, and Pharmacovigilance areas 
  • Prepare and implement audit plans for all CROs, testing laboratories and clinical treatment centers 
  • Manage audit system and follow up on corrective action and CAPA to complete audit certifications 
  • Collaborate with our company  US, UK and EU Clinical Research staff to assure all applicable groups are inspection ready and operate in a complaint manner with applicable regulatory guidance. 
  • Lead, develop and implement all GCP regulatory inspection readiness activities 
  • Lead and host EMA inspections, provide follow up to any responses and corrective actions 
  • Provide leadership and direction for - CAPAs, Deviations, and other reports 
  • Provide periodic reports to company management on the quality and compliance status of the company  GCP quality system and Clinical Research teams. 
  • Provide periodic reports on the GCP compliance status of all outside CRO, testing lab and treatment centers 
  • Ability to travel up to 25% 
  • Perform other duties as assigned. 

  • Bachelor s degree in biological sciences or related field with minimum of 6 years  experience in a pharmaceutical or affiliated medical/clinical role.  Advanced degree is desirable. 
  • Experience with vaccines or biologics along with cold chain in a pharmaceutical setting a plus. 
  • Experience in performing a wide array of GCP audits 
  • Experience with direct European Health authority inspections and interactions 
  • Experience writing, evaluating and closing investigations and CAPA records. 
  • In-depth knowledge of and ability to apply GCP in conformance to US, EU and ROW standards 
  • Proficient in MS Word, Excel, and Power Point 
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment 
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies 
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities 
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description. 


Amsterdam Netherlands

Find a Job Find Candidates

Similar Jobs

More jobs from Kite Pharma

Other jobs in Netherlands

Other jobs in Amsterdam

Other similar job in Amsterdam

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like