Technical Developer Quality Lead
vor 2 Monaten
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.
Here's what we offer
Up to 30 days vacation per year Option of permanent employment with our business partner Extensive social benefits, incl. Christmas and holiday bonuses
Your tasks
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
Your profile
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-
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