Time for change – time for a new job! You are a technical developer quality lade and looking for a new professional challenge? Then stop searching! We offer the job you are looking for: Our subsidiary Randstad professional solutions offers a secure job, fair compensation and exciting new tasks at an attractive pharmaceutical company in Holzkirchen. Apply online now! We welcome applications from all suitably qualified persons regardless of any 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