GCP Compliance Manager - Quality Assurance (m/f)

Main focus: Quality Assurance
Date posted: 02.11.2021
Location: Vienna

Position Summary

The Quality Assurance department at HOOKIPA has an open Manager position, who will actively contribute to strengthen and maintain GCP compliance within in the company. As part of the growing department the incumbent will provide expertise and guidance regarding regulatory requirements in the GCP area. This position will serve as point of contact for GCP compliance support. As an expert, the GCP Compliance Manager will utilize a risk-based strategy to prioritize Quality support for clinical trial activities, identify and escalate compliance issues, enable pro-active decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition, the position will partner with other key functions to enable transparency and escalation of quality and compliance matters. The ideal candidate has a hands-on mentality, is analytically skilled and problem-solving oriented as well as he or she is detail-oriented, driven, independent, and able to respond quickly to evolving needs. The ability to work in a fast-paced environment and professionalism are all essential behaviors for this role. Implementation into day-to-day practice and constant evaluation of the applied processes will be tools for the Manager to help to continuously improve the established systems.

Main Responsibilities
  • Provide support and assistance to the Clinical Developments team to ensure delivery of the portfolio according to Good Clinical Practice (GCP).
  • Oversee quality assurance (QA) activities related to FDA and Rest of World (ROW) regulations across therapeutic areas and provide GCP guidance for all phases of drug development.  Act as GCP expert and provide support to other functions. 
  • Constantly monitor the GCP compliance status, identify and escalate significant compliance issues to the QA team and take responsibility to close potential gaps
  • Closely collaborate with the Clinical Operations team to further enhance day to day practice related to GCP.
  • Assist in further developing GCP vendor management. Perform external vendor/ supplier audits for clinical activities as defined in Audit Schedule and as needed.
  • Prepare and organize GCP self-inspections.
  • Assist in managing core clinical and QA processes including being owner for some agreed Quality Management System processes, as applicable.
  • Identify and anticipate trends in quality issues and collaborate with department management to ensure risk-managed solutions are implemented in a timely fashion.
  • Maintain high level of expertise in international GCP regulations that may impact drug development.
  • Development of new SOPs and edits to existing SOPs per GCP requirement together with other involved functions.
  • Supporting/leading GCP Quality investigations.
  • Expert knowledge of GCPs particularly FDA and ICH requirements. Support the preparation and management of regulatory authority inspections.
  • Give consultative assistance to Head of QA and Functional area(s) in relation to clinical QA / risk questions/issues.
  • Facilitate the development, monitoring, and continuous improvement of CAPAs / risk mitigation plans and effectiveness checks.
  • May provide oversight to contracted consultants and contracted auditors

Qualifications

  • Excellent knowledge of GCP and GCLP
  • Degree in scientific, health sciences or quality related field
  • At least 5 – 6 years of pharmaceutical or biotechnology industry experience in a GCP related discipline and/or clinical operation's experience. Strong preference to candidates who have worked as a CRA monitor or in Clinical Trial Management in their previous work experience. 
  • Expert knowledge of international GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH Guidelines
  • QA experience in creating template of documents that are needed to be GCP compliant.
  • Previous experience managing quality and GCP compliance issues
  • Strong collaborative, partnering, and interpersonal skills
  • Has attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
  • Fluent in English, both spoken and written
  • Competence in Microsoft Office Tools

What we offer

  • Strong team with dedicated and passionate employees
  • State of the art infrastructure
  • An excellent working atmosphere
  • Opportunities for personal development
  • Working in a multinational and multicultural environment
  • Help with shaping the Quality System of a growing biopharmaceutical company

We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 3.857,-- based on fulltime (40 hours per week); depending on experience and qualification salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.

Starting date: as soon as possible

Apply Now!

Contact
Gwenaelle Kerforn Executive Director Human Resources