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Associate Director, GCP Quality – R&D QA

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Life Science Talent

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Location:
Denmark , Søborg

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

Are you passionate about providing pragmatic, risk-based quality leadership that enables high quality clinical development? Do you have solid expertise in Good Clinical Practice (GCP) and enjoy guiding teams through complex development challenges? If so, this could be your opportunity to join Zealand Pharma as Associate Director, GCP Quality in R&D QA.

Job Responsibility:

  • Lead quality oversight for specific clinical development projects or defined components, ensuring alignment with GCP and internal QMS requirements
  • Provide expert, risk-based QA guidance to clinical trial teams, particularly during trial startup and execution of critical milestones
  • Serve as a key resource and mentor for QA Managers within your area of expertise
  • Drive and support GCP training for Development organization
  • Plan, conduct, and oversee audits (e.g., GCP, GvP, GLP) and ensure timely, effective follow-up of audit findings
  • Support and contribute to inspection readiness activities and regulatory inspections, including preparation, hosting support, and responses
  • Lead or support assessment and management of suspected serious breaches related to clinical trials, including escalation and documentation
  • Drive cooperation with our preferred service providers QA functions according to established Clinical Quality Agreements.
  • Oversee and drive quality events such as deviations, CAPAs, and change controls, applying sound judgment to resolve complex issues
  • Lead continuous improvement initiatives within the development QMS, incorporating industry trends and regulatory expectations
  • Lead and/or contribute to the GCP SOP Committee, ensuring high quality, consistent QMS documentation and aligned training
  • Engage effectively with internal and external stakeholders to ensure cohesive execution of project objectives and strategic goals
  • Make impactful decisions within defined project components or functional areas, addressing complex problems with structured methodologies

Requirements:

  • Solid experience in clinical trial management and/or QA/compliance within clinical development. Typically, 10+ years of industry experience within clinical development and preferably at least 2+ years in QA/Compliance roles.
  • Strong, in-depth knowledge of GCP
  • familiarity with GvP and/or GLP is an advantage
  • Proven experience conducting audits, supplier qualification, and supporting regulatory inspections
  • Hands-on experience managing deviations, CAPAs, and change control in a regulated environment
  • Demonstrated ability to apply risk based thinking to deliver compliant, pragmatic solutions
  • Strong communication and stakeholder management skills, with the ability to influence and lead without formal authority

Additional Information:

Job Posted:
March 14, 2026

Expiration:
March 23, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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