QA Manager

Let’s shape the future - University of Antwerp

The University of Antwerp is a dynamic, forward-thinking, European university. We offer an innovative academic education to more than 20 000 students, conduct pioneering scientific research and play an important service-providing role in society. We are one of the largest, most international and most innovative employers in the region. With more than 6000 employees from 100 different countries, we are helping to build tomorrow's world every day. Through top scientific research, we push back boundaries and set a course for the future – a future that you can help to shape.

Within the European Plotkin Institute for Vaccinology, a collaboration between University of Antwerp and Université libre de Bruxelles, we are currently building a state-of-the art centre for vaccine trials (“Vaccinopolis”) and immunology – headed by Prof. Pierre Van Damme and Prof. Arnaud Marchant – to accelerate the evaluation and development of vaccine candidates and to participate in the global efforts for better pandemic preparedness. Vaccinopolis will start operations in Q2 2022. Now is the “momentum” and unique opportunity to join the team, at the very first growing and shaping steps.

The European Plotkin Institute is looking for a full-time QA manager

Embedded in European legislation (e.g. Commission Directive 2005/28/EC), Good Clinical Practices (GCP) are the international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Moreover, the clinical samples should be tested according Good Clinical Laboratory Practises (GCLP). Compliance with these standards provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible. Additional requirements are imposed by authorities and sponsors for conducting clinical studies with humans.

We are seeking a QA manager which will closely work with the clinical trial unit manager and other members of the clinical team. This work implies a proactive, realistic and intelligent approach to GCP and GCLP, an engagement with clinical trial projects and analytical services.

Job Responsibility

Compliancy with GCP and GCLP

Ensures that the activities related to the clinical testing and to the analytical services are compliant with GCP and GCLP. This implies:

• review and signing off of all related documentations
• ensure that all personnel have been trained on the respective procedures they need in their job
• ensure that all the equipment is validated
• supervise and review the studies related to analytical method development and method validation.
• manage all non-conformities and follow-up the CAPA database. Will take immediately the required action in case of non-conformities.
• conduct and/or manage internal audits to ensure compliance to all relevant policies and procedures

 Third party interaction

• Coordination with Health, (Bio)Safety and Environmental functions is essential to streamline the day-to-day implementation. External parties include sponsors and CRO’s as well as FAMPH services, e.g. during inspections.
• Supports the clinical trial team in scientific advice meetings (on quality related aspects)
• Participates in audits performed by sponsors, FAGG inspections or other regulatory authorities, including the site registration
• Is responsible for sponsor complaint investigations, including data collection, root cause analysis, internal report, issuing responses and corrective follow-up

 Follow up of Regulation

• Follows up directives, regulations and guidelines.
• Assesses the impact of new or adapted directives, regulations, and guidelines on the quality management system.
• Communicates changes, ensure that the quality system documentation is up to date and changes are implemented

Active participation in the management of Vaccinopolis and the European Plotkin Institute for Vaccinology

• Contributes to the development of the quality strategies
• Provides QA support and QA coaching to the members of the clinical team and to the analytical group
• Anticipates areas of risk, and plan and implement solutions to mitigate these risks in collaboration with the clinical team manager
• Demonstrates a collegial, collaborative interpersonal style and the ability to implement QA approaches that requires consensus and engagement across the Institute
• Follows up on Data compliance in conjunction with clinical trial team and the management

Profile

To be successful in this role the following profile will be required:

• A master degree or a Ph.D preferably in life science or pharmacy or a medical degree
• 5+ years working experience in a biotech, pharmaceutical or CRO environment
• Working knowledge of current quality standards and various guidelines such as GCP, GCLP, GDPR
• A result-oriented and flexible attitude
• Fluent in English (spoken and written)
• Excellent reporting and presentation skills
• Ability to work independently as well as a member of a team in a dynamic and fast-paced environment
• Willingness to work 50% at the University of Antwerp (Campus Drie Eiken) and 50% at the Université libre de Bruxelles

Asset

• Registered Pharmacist
• Good knowledge of Dutch and French

 What we offer

• We offer a fulltime appointment for an unlimited period. The payscale of your appointment is equivalent to that of professor (assistant professor, associate professor, professor or full professor) and is determined on the basis of your professional experience and academic qualifications.
• Your gross monthly salary is calculated according to the pay scales for a visiting professor in the Contract Research Staff category (Dutch: Bijzonder Academisch Personeel, BAP).
• The planned start date is 1 January 2022 or as soon as possible after that date.

Want to apply?

• You can apply for this vacancy through the University of Antwerp’s online job application platform up to and including November 8th 2021 (by midnight Brussels time). Click on 'apply', complete the online application form and don’t forget to include the following document(s): (1) a motivation letter, (2) your CV.
• The selection committee will review all of the applications as soon as possible after the application deadline. As soon as a decision has been made, we will inform you about the next steps in the selection procedure. Please make a note of the following date: 23 Nov , 2 pm - 5 pm.
• If you have any questions about the online application form, please check the frequently asked questions or send an email to [email protected] . If you have any questions about the job itself, please contact: Martina Bamberger, Valorization Manager, [email protected] .

The University of Antwerp received the European Commission’s HR Excellence in Research Award for its HR policy. We are a sustainable, family-friendly organisation which invests in its employees’ growth. We encourage diversity  and attach great importance to an inclusive working environment and equal opportunities, regardless of gender identity, disability, race, ethnicity, religion or belief, sexual orientation or age. We encourage people from diverse backgrounds and with diverse characteristics to apply.