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Director, Good Clinical Practice - Netherlands  

Company managed [?] Still accepting applications
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Posted on : 01 June 2017

Project Description

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. 
 


Requirements:                                        
  • 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.