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Technical Developer Quality Lead
vor 2 Monaten
Job Summary
Randstad Deutschland is seeking a highly experienced Technical Developer Quality Lead to join our team in the pharmaceutical industry. As a key member of our quality assurance team, you will be responsible for providing robust and clear quality oversight in clinical development.
Key Responsibilities
- Provide quality oversight in clinical development, ensuring compliance with regulatory requirements and industry standards.
- Collaborate with key stakeholders to ensure quality-by-design for projects under responsibility.
- Establish and lead quality issue management governance for critical or major quality issues.
- Provide regulatory guidance to day-to-day questions arising from clinical trials deliverables.
- Collaborate with stakeholders to drive initiatives relevant to internal monitoring and quality oversight for outsourced activities.
- Support inspection preparation and facilitation in collaboration with other QA groups.
- Participate in audits and inspections, 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 defined development projects and audits.
Requirements
- 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 a strong quality mindset.
- Several years of experience in managing projects, preferably from a clinical quality assurance perspective.
- Solid understanding of global expectations of health authorities in the area of clinical 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.
What We Offer
- Option of permanent employment with our business partner.
- Up to 30 days of vacation per year.
- Extensive social benefits, including Christmas and holiday bonuses.