Technical Lead for Quality Assurance

vor 3 Wochen


Holzkirchen, Bayern, Deutschland GULP – experts united Vollzeit

Are you looking for a challenging and rewarding role where you can make a real impact? We have an exciting opportunity for a Technical Developer Quality Lead at our pharmaceutical company in Holzkirchen. As a key member of our team, you will be responsible for providing robust and clear quality oversight in clinical development, ensuring that our projects meet the highest standards of quality and regulatory compliance.

Key Responsibilities:

  • Provide quality oversight in clinical development, ensuring that projects meet regulatory requirements
  • Collaborate with key stakeholders to ensure quality-by-design for clinical trials
  • 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, and participate in audits and inspections
  • 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

Requirements:

  • Several years of 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

About Us:

We are GULP – experts united, a leading provider of pharmaceutical solutions. We value equal opportunities and welcome applications from people with disabilities. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.



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