Do you want to progress professionally and desire a job where you are challenged and supported? With regular working hours, good benefits, and diverse opportunities for further development? Then you've come to the right place: Our subsidiary Randstad professional solutions offers an attractive position as technical developer quality lead at a pharmaceutical company in Holzkirchen. Apply online right away. We value equal opportunities and welcome applications from people with disabilities.
Das dürfen Sie erwarten
* Up to 30 days vacation per year
* Option of permanent employment with our business partner
* Extensive social benefits, incl. Christmas and holiday bonuses
Ihre Aufgaben
* Provide robust and clear quality oversight in the following areas of clinical development
* Proactively support and collaborate with key stakeholders to ensure clinical Quality-by-Design for the projects under responsibility
* Establish and lead core Quality Issue Management governance for critical or major quality issues pertinent to the programs being assigned and ensure timely escalation when required
* Provide regulatory guidance to day to day questions arising from Clinical trials deliverables
* Collaborate with key stakeholders to drive initiatives relevant to internal monitoring and dispense strong Quality oversight for outsourced activities
* Support inspection preparation and facilitation in collaboration with other QA groups including but not limited to Regulatory Affairs Quality and Compliance
* Participate in audits and inspections, as applicable, and follow-up activities including CAPA preparation and implementation
* Provide lessons learned from deviations and incidents, audits and inspections
* Actively leverage audit and inspection outcomes and trends to sustain improvement in clinical trials conduct
* Act as the point of contact for quality assurance in the defined development projects and audits, attending the relevant meetings and ensuring that quality is included in the decision-making processes
Unsere Anforderungen
* Several years of solid experience in regulated activities, GCP and GLP, preferably in QA positions
* Experience from positions in clinical development and/or compliance, with strong quality mindset in focus
* Several years experience in managing projects, preferably from Clinical Quality Assurance perspective
* Solid understanding of global expectations of Health Authorities in the area of Clinical Development and pro-found understanding of the science of product development
* Ability to work independently in a global and matrix Environment
* Strong skills in GCP, quality or clinical development
* Strong interpersonal, communication, negotiation, and problem solving skills
* Fluency in English and German oral and written