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Executive Director Quality (Site Head)

Netherlands - AmsterdamQualityRegular

Descripción del trabajo

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit a highly motivated and experienced leader with a demonstrated track record of leading teams in a GMP/ATMP manufacturing environment for the role of Executive Director of Quality at our commercial manufacturing site in Hoofddorp, the Netherlands. This role will report to the Vice President of Quality - Commercial Manufacturing and will sit on the Commercial Quality Leadership Team to ensure alignment of Quality management systems across our expanding global operations; it will also be a member of the Site Leadership Team (SLT).

Your Responsibilities

In this role you will lead GMP Quality functions at the site, including Quality Systems, Quality Operations, Quality Engineering and Quality Control. You will also utilize Quality tools such as lean, six sigma, risk management and other risk-based tools to continually improve Quality operations.  

Your Responsibilities will be (included but not limited to):

  • Represent all Quality functions on the site leadership team
  • Site and functional leadership, including management of technical staff
  • Quality Operations including lot disposition, audits and deviation management 
  • Quality Systems including document management, change control, CAPA and Quality policy management
  • Quality Control incoming goods; analytical, microbiological and environmental monitoring, and laboratory management
  • Inspection Management at the site conducted by US FDA and other regulatory health authorities
  • Develop and implement annual Quality plan for site, including site departmental goals, action plans and budgets
  • Quality metric reporting to executive management through Management Review process
  • Responsible for talent management including recruitment, selection, development, training and retention of Quality staff at the site. Ensures proper Quality skill sets and competencies are consistent with business and technology plans
  • Collaborate with product sciences, manufacturing, translational sciences, engineering and clinical groups
  • Ensure effectiveness of site Quality training system
  • Establish the site annual internal Quality system audit schedule and maintain the site internal audit system
  • Oversight of technology transfers of new clinical and commercial products
  • Oversee review and approval of process and method validation; qualifications and validation reports; change control documents; and technical reports
  • Other duties as assigned

Your Profile

The ideal candidate for this position will have the following qualifications:

Basic Qualifications:  

  • PhD or MS Molecular Biologist or Biochemist preferred with 14 years of technical experience of which at least 7 years Quality management experience

Preferred Qualifications: ​

  • Advanced degree is a plus (education/training or experience in ATMPs, cell culture or gene therapy)
  • Proficient in application of cGMPs (such as Eudralex Volume 4 ATMP, EMA, ICH and US FDA GMP and GCP) and proven track record of successfully implementing these requirements phase appropriately
  • Strong knowledge of fundamental Quality (Engineering) principles, such as technology transfer, process validation, process capability, process control and aseptic manufacturing
  • Demonstrated ability to successfully interact with regulatory health authorities at inspections
  • Strong organizational, planning and problem-solving skills. Able to manage competing priorities creating an effective team environment
  • Strong leadership skills that include:
  • Ability to lead and influence cross-functional employees to ensure compliance
  • Ability to effectively present information in small and large group situations to staff, customers, regulators and executive management
  • Demonstrated ability to engage, lead and motivate a large and diverse group of Quality professionals in a fast-paced environment
  • Demonstrated ability to develop, coach, and mentor key employees. Excellent interpersonal, verbal and written communication skills
  • Proficient in MS Word, Excel, Power Point, Visio, Project and statistical software