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Director, Qualified Person - Netherlands  

Company managed [?] Still accepting applications

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. 
  • We are seeking a highly motivated individual to join us as a Director.
  •  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 requirements.
  •  This role will be a hands-on resource reporting to the company quality head.

 

Responsibilities (include but are not limited to):
Responsible for working with the company quality team to :
  • Develop and implement quality systems for company European operations 
  • Develop and implement company Qualified Person (QP) process for product disposition within the EU member countries. 
  • Assist in disposition issue resolution related to manufacture and testing of vectors and final product from US and European sites.  
  • Perform QP site and laboratory qualification activities for company
  • Manage audits with Clinical Research Organizations (CRO), contract testing labs, contract manufacturing sites and raw material suppliers. 
  • Manage cross-functionally within company and externally to assure compliance and strong relationships with raw material suppliers. 
  • Collaborate with company Supplier Quality Management (SQM) and Supply Chain teams to improve:  
    • supplier qualification and specification development processes that will use risk-based tools for qualification, classification and monitoring. 
    • supplier QTA process and assure a process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed. 
    • Supplier initiated change notifications   
  • Monitor and report on meaningful performance metrics 
  • Provide leadership and direction for - SCARs, CAPAs, and Deviations. 
  • Support inspection readiness plans and interact with regulatory agencies during inspections as needed. 
  • Ability to travel up to 25% 
  • Perform other duties as assigned. 
 



Requirements:                                        
  • Registered QP in The Netherlands. 
  • Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in a pharmaceutical or biologics role.  Advanced degree is desirable. 
  • Previous experience managing and developing staff with a minimum of 6 years of experience. 
  • Experience auditing CMOs, CTLs and/or CROs.  
  • Experience with direct European Health authority inspections and interactions 
  • Experience writing, evaluating and closing investigations, CAPAs and change control records. 
  • In-depth knowledge of and ability to apply GMP 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.