Clinical Development Quality Assurance Lead

vor 1 Woche

Holzkirchen, Bayern, Deutschland GULP – experts united Vollzeit

Grow Professionally with Us

We are seeking a highly motivated Clinical Development Quality Assurance Lead to join our team at GULP – experts united. This exciting opportunity allows you to progress professionally, work with a talented team, and take on new challenges.

Here's What We Offer

  • A dynamic work environment with regular working hours and good benefits
  • Opportunities for further development and career progression
  • A chance to work in a global and matrix environment

Your Responsibilities

As a Clinical Development Quality Assurance Lead, you will be responsible for providing robust and clear quality oversight in clinical development areas. You will proactively support and collaborate with key stakeholders to ensure clinical Quality-by-Design for projects under your responsibility.

Your tasks will include establishing and leading core Quality Issue Management governance for critical or major quality issues pertinent to the programs being assigned, ensuring timely escalation when required. You will also 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.

Additionally, you will support inspection preparation and facilitation in collaboration with other QA groups, including Regulatory Affairs Quality and Compliance. You will participate in audits and inspections, as applicable, and follow-up activities, including CAPA preparation and implementation.

You will also provide lessons learned from deviations and incidents, audits, and inspections, actively leveraging audit and inspection outcomes and trends to sustain improvement in clinical trials conduct. Finally, you will act as the point of contact for quality assurance in defined development projects and audits, attending relevant meetings and ensuring that quality is included in decision-making processes.

Your Profile

To be successful in this role, you will need several years of solid experience in regulated activities, GCP, and GLP, preferably in QA positions. You will also have experience from positions in clinical development and/or compliance, with a strong quality mindset in focus. Additionally, you will have several years of experience in managing projects, preferably from Clinical Quality Assurance perspective.

You will have a solid understanding of global expectations of Health Authorities in the area of Clinical Development and a profound understanding of the science of product development. You will also be able to work independently in a global and matrix environment and have strong skills in GCP, quality, or clinical development. Finally, you will have strong interpersonal, communication, negotiation, and problem-solving skills, as well as fluency in English and German oral and written.

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