Technical Developer Quality Lead

vor 2 Wochen

Holzkirchen, Bayern, Deutschland Randstad Deutschland Vollzeit

Job Summary:

We are seeking a highly experienced Quality Assurance Lead to join our team at Randstad Deutschland. As a Quality Assurance Lead, you will be responsible for providing robust and clear quality oversight in the areas of clinical development, ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities:

  • Provide quality oversight and guidance to ensure compliance with regulatory requirements and industry standards.
  • Collaborate with key stakeholders to ensure quality-by-design for clinical trials and projects.
  • Establish and lead quality issue management governance for critical or major quality issues.
  • Provide regulatory guidance and support 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.

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