Technical Developer Quality Lead (f/m/d) für Holzkirchen, Oberbayern gesucht

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Job Kategorie: Medizin/Pharma/Biotech Medizin/Pharma/Pflege

Stellenangebot Basisdaten

Arbeitsort:: DE 83607 Holzkirchen, Oberbayern
Umkreis:: keine Angabe.
Art der Arbeitsstelle:
Letze Aktualisierung:: 30.09.20242024-09-30

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Stellenausschreibung: Technical Developer Quality Lead (f/m/d)

Arbeitgeber bzw. Arbeitsvermittler: Randstad Deutschland in Mannheim

Branche: Medizin/Pharma/Biotech

Kategorie: Medizin/Pharma/Pflege

Stellenbeschreibung: 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

Qualifikation: Arbeitskräfte

Verdienst:: 32767.00 - 32767.00 EUR

Bewerbung an: Randstad Deutschland
Reichskanzler-Müller-Str. 21
De 68165 Mannheim
Telefon: +49 1525 4507336
Email: fiona.krafft2@randstad.de

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