vor 3 Tagen

QA/RA manager

AARDEX Group (Switzerland) SA

  • Arbeitsregion
  • Branche
  • Anstellungsart
  • Position

AARDEX Group develops and markets solutions to manage medication adherence in clinical trials. Our customers are pharmaceutical and biotechnological companies which implement adherence solutions to speed up Clinical Drug Development.

For over 35 years, AARDEX is the world market leader in clinical trials (200+ drug trials) and research settings (800+ peer-reviewed publications) with more than 1 million patients monitored across 70+ countries.

This experience results in long-established key client relationships with most major pharmaceutical and biotechnology companies, primarily in the US and in Europe. AARDEX’s products are end-to-end software and hardware adherence patented solutions.

The mission of AARDEX Group is to develop and market eco-systems to measure, analyze, and exchange dosing history data to support successful management of patients' adherence to medications.

The vision: Data driven adherence feedback enabling digital therapeutics and patient empowerment.

 

Context

AARDEX’s customers are research-based pharmaceutical or biotechnological companies with a drug

pipeline in development phase (II or III).

The AARDEX solutions are used primarily during clinical trials, whereby the measured patient adherence

data are used by the Sponsor, CRO’s and sites to ensure fidelity to the research protocol.

In order to ensure its growth, AARDEX is looking for a quality and regulatory affairs manager. The job is also open to a junior profile, that is highly motivated to gain quickly new competences both in QA and regulatory affairs.

 

 

QA/RA manager

AARDEX Group develops and markets solutions to manage medication adherence in clinical trials. Our customers are pharmaceutical and biotechnological companies which implement adherence solutions to speed up Clinical Drug Development.

For over 35 years, AARDEX is the world market leader in clinical trials (200+ drug trials) and research settings (800+ peer-reviewed publications) with more than 1 million patients monitored across 70+ countries.

This experience results in long-established key client relationships with most major pharmaceutical and biotechnology companies, primarily in the US and in Europe. AARDEX’s products are end-to-end software and hardware adherence patented solutions.

The mission of AARDEX Group is to develop and market eco-systems to measure, analyze, and exchange dosing history data to support successful management of patients' adherence to medications.

The vision: Data driven adherence feedback enabling digital therapeutics and patient empowerment.

 

Context

AARDEX’s customers are research-based pharmaceutical or biotechnological companies with a drug

pipeline in development phase (II or III).

The AARDEX solutions are used primarily during clinical trials, whereby the measured patient adherence

data are used by the Sponsor, CRO’s and sites to ensure fidelity to the research protocol.

In order to ensure its growth, AARDEX is looking for a quality and regulatory affairs manager. The job is also open to a junior profile, that is highly motivated to gain quickly new competences both in QA and regulatory affairs.

 

 

Responsibilities as quality manager

  • Manage and further develop the quality management system

  • Take in charge the upgrade from ISO 9001 to ISO 13485

  • Pass audit by customers and notified body, audit internal process and suppliers

  • Manage customers interaction regarding satisfaction and product quality

  • Collect, analyze, and report data to management


Responsibilities as Regulatory affairs manager

  • Define and apply the regulatory pathway for AARDEX’s products, primarily software

  • Take in charge the regulatory process to certify as medical device (both EU EMA and US FDA)

  • Control and validate the compliance of the processes 

  • Communicate with authorities and customers about regulatory affairs


Role and responsibilities as AARDEX Group employee

  • Be open-minded, proactive and team player

  • Be an entrepreneur, taking part to strategic decisions and company success

  • Act as AARDEX group ambassador, promoting our values


Profile and competencies

  • Experience in implementing and maintaining ISO 13485

  • Experience in medical device regulations, both in EU and US

  • Experience in the pharmaceutical industry is an asset

  • IT background and knowledge of ISO 62304 is an asset

  • Good project management skills 

  • Ability to handle priorities, stress and deadlines

  • Interpersonal skills and capacity to interact in a multi-disciplinary team

  • Ability to work under limited supervision

 

Starting date: as soon as possible

Please send a CV and accompanying letter to job@aardexgroup.com

 

 

 

Avenue de la Gare 29 1950 Sion