Editor: 

The Breast International Group (BIG) is a non-profit research organization that represents the largest global network of academic groups dedicated to breast research. 30+ clinical trials are run or under development under the BIG umbrella at any one time. BIG is looking for a:

QUALITY MANAGER

Function: Responsible for the quality management system (QMS) and operational standards of the association

Primary Responsibilities:

  • Manage the development and implementation of the QMS
  • Participate in the analysis of the organization’s processes, keeping inventory of current procedures, identifying missing procedures and initiating procedures to be developed
  • Write SOPs, policies, templates, work instructions, guidelines and other related documents that reflect the organization’s working procedures and comply with ICH/GCP requirements (when applicable)
  • Coordinate the review of QMS documents
  • Review and update existing QMS documents as needed
  • Serve as designated in-house expert for ICH-GCP issues
  • Coordinate the preparation of audits and inspections
  • Lead in the preparation and implementation of CAPA plans following audits or inspections
  • Support compliance monitoring and continuous improvement initiatives
  • Manage non-conformities and quality incidents in consultation with R&D Director, Research Operations Director and/or CEO/Deputy CEO
  • Advise the R&D Director, Research Operations Director and CEO/Deputy CEO on quality issues in general
  • Liaise with external QA expert as determined in consultation with CEO/Deputy CEO
  • Review study documents (including but not limited to protocols, main study agreement(s), scopes of work, participant information sheets and informed consent forms, ,…) for senior input and standardization
  • Work with the HR training manager and the department directors on the development of the training matrix and some training materials, as needed.
  • Communicate effectively in multicultural teams within BIG Headquarters, and across organisational boundaries, respecting differences between people from a variety of linguistic and cultural backgrounds

Qualifications sought:

  • Academic degree, preferably in a (para)medical discipline
  • Experience as a Quality Manager with a good knowledge of ICH-GCP and methodologies, regulations and procedures related to clinical trials
  • Experience in the set-up and management of all operational aspects of clinical trials (in academia, industry, or CRO)
  • Experience in oncology clinical trials is a plus
  • Possess strong analytical skills, working in a highly organized way,  keeping an eye on both detail, while maintaining a broad overview
  • Native or native-like written and spoken English; French, Dutch or other languages are a plus
  • A high level of integrity and sense of responsibility and professionalism

What we offer:

  • The opportunity to contribute to innovative, practice-changing cancer research
  • A stimulating international environment
  • Work regimen at 40% as a part-time employee with an unlimited duration employment contract or as a consultant
  • A competitive salary and benefits package for an employment contract:
    • Annual salary on 13.92 months
    • Possibility to telework and have flexible working hours
    • Employee group insurance (employer contribution 4% & employee contribution 2% on annual gross salary)
    • Hospitalization insurance at employer charge only for the employee
    • Intervention public / private transport
    • Luncheon vouchers - Face value EUR 8,00 - employee contribution: EUR 1,09 per working day
    • Eco vouchers - annual net value of 250 EUR/Year for full year full time from July to June
    • Mobile phone according to internal policy (Benefit in kind will apply if private use as per the legislation)

Send your cover letter and CV to recruitment@BIGagainstbc.org