uniQure

Site Quality Manager Amsterdam - Amsterdam

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Active since 31-05-2018 Job category Quality / Health / Environment ...
Location Amsterdam Level Mid-Senior level
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Site Quality Manager Amsterdam

Based in Amsterdam and Lexington (USA), uniQure is a biotech company dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility is part of our day-to-day working life by living up to high quality standards and by recognizing the sense of urgency in areas of high medical need.

Due to some changes there is an immediate requirement for an experienced Site Quality Manager in Amsterdam to join our company.

The role:

You will develop, implement, maintain, and improve GCP and GLP Quality Management Systems per global regulations in clinical and pre-clinical operations, which include: Clinical, Research & Development, Pharmacovigilance, Medical Affairs, Regulatory Affairs, Laboratories, and vendors.

You will also promote collaboration with all functional areas to ensure compliance with applicable global GCP and GLP regulations and company’s Quality Management Systems.

Managing GCP/GLP audits to assure that all aspects of clinical trials conducted have been executed in compliance with applicable EMA, FDA, ICH Guidelines and other government and/or country specific regulations will also be part of the role.

Your responsibilities:

  • Ensure all applicable clinical Quality Assurance responsibilities are followed.
  • Maintain QA systems and SOPs for GCP and GLP activities.
  • Ensure compliance of clinical development and laboratory activities to applicable quality and regulatory requirements.
  • Ensure all audits are conducted, reported, tracked and closed.
  • Plan, track and oversee audits of internal and external contract laboratories, contract research organizations (CROs) and investigator sites.
  • Review GLP study protocols and reports, clinical study reports, etc.
  • Provide QA support to identify GCP-related issues and develop corrective action plans
  • Work in collaboration with internal and external stakeholders (CROs, clinical sites, Clinical Operations) to ensure compliance with GCPs and to maintain inspection readiness.
  • Ensure all applicable clinical Quality Assurance responsibilities are followed.
  • Maintain QA systems and SOPs for GCP and GLP activities.
  • Ensure compliance of clinical development and laboratory activities to applicable quality and regulatory requirements.
  • Ensure all audits are conducted, reported, tracked and closed.
  • Plan, track and oversee audits of internal and external contract laboratories, contract research organizations (CROs) and investigator sites.
  • Review GLP study protocols and reports, clinical study reports, etc.
  • Provide QA support to identify GCP-related issues and develop corrective action plans
  • Manage site specific GMP operations (i.e. P & L, Documentation, Auditing, and Training) with support from US QA and QP
  • Work in collaboration with internal and external stakeholders (CROs, clinical sites, Clinical Operations) to ensure compliance with GCPs and to maintain inspection readiness.
  • Responsible for 50% GCP 30% GLP and 20% GMP oversite and management


You will need:

  • A Bachelor’s degree in Molecular Biology, Biochemistry or Chemistry. An advanced degree is preferred.
  • A minimum of 6 years of experience biopharma industry in a Clinical Quality GLP or Regulatory role.
  • At least 2 years of experience in a leadership role managing Clinical Quality Assurance organization and GCP and GLP operations.
  • A thorough knowledge of clinical Quality Assurance principles and best practices
  • The ability to manage complex relationships between various professional disciplines and organizational levels.
  • Good stakeholder management and team leader skills, able to collaborate across all levels of the organization with an open attitude.
  • An excellent ability to manage change with the ability to overcome resistance and persist in achieving our Quality mission.
  • Strong communication and listening skills, with the ability to present information verbally and in written format.
  • A self-propelling - learning & (Quality) improvement mind-set and change management.
  • A hands-on mentality to get the job done.
  • A drive for continuous improvement; making use of the lessons learned.
  • A strong analytical ability with a pragmatic attitude.

 

What we have to offer:

Beyond a competitive remuneration package, working at uniQure brings many perks and exciting opportunities. How about a very international workforce; a work environment that offers room for fun and inspiration; a generous education budget; a discount on fitness and a very nice, brand new office.

More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region Netherlands
Keywords

Contact information

Name Marsha Lemmers

Location

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