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Director of Clinical Quality Assurance Operations

Become responsible for all clinical QA operations in a growing global biopharmaceutical company.


As Director of Clinical Quality Assurance Operations at Orphazyme, you will be overall responsible for quality in all clinical operations. This includes developing and maintaining audit tools and good quality principles throughout the drug development process. You will design risk mitigation strategies for programs and ensure that they are implemented.

Furthermore, you will be responsible for ensuring that quality metrics, including audits, are utilized to inform the business of the state of quality of the programs within their respective therapeutic areas, while also ensuring the quality and integrity of generated data, and the rights and welfare of study participants. You will identify audit targets and conduct audits and ensure that quality standards are consistently applied throughout the clinical operations.

With direct report to Global Head of QA.

Your main tasks are:

  • Lead GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites. Facilitate appropriate and timely inspection responses and follow-up actions
  • Lead and manage a range of GCP and/or Good Pharmacovigilance Practice (GPVP) audits, including complex audits (i.e. directed, for-cause), for a given program, across a program, therapeutic area or region
  • Represent Quality Assurance (QA) as the single point of contact for clinical development programs and provide QA strategic guidance
  • Provide professional expertise and guidance on GCP and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
  • Interface with relevant stakeholders, including regulatory, clinical and development subteams, as appropriate, to provide Good Clinical Practice, Pharmacovigilance and QA expertise
  • Actively participate in Significant Quality Issue management, including assessment of potential root causes and remediation (corrective and preventative actions)
  • Ensure rapid communication of QA issues including potential misconduct or issues of significant deviation within project/products to appropriate leaders and colleagues
  • Provide inspection management support as needed
  • Manage personnel or assist with the management of personnel and planning functional group activities to achieve functional area and/or departmental objectives, as applicable
  • Provide guidance and collaborate with other QA personnel, as appropriate, to ensure adequate audit focus and timely knowledge transfer

The preferred candidate has a minimum of 10 years of experience in the pharmaceutical, biotechnology or related healthcare industry together with a minimum of 7 years of GCP-related Quality Assurance or relevant clinical trial experience.

You have extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development, and you have advanced knowledge of the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity. Experience with QMS systems and audit tools is preferred. Finally, you have strong technical writing skills, which includes writing quality positions, audit reports, and procedures.

You hold a Bachelor’s degree in Pharmacy or other scientific disciplines.

You are a person with strong decision-making skills and work towards tight deadlines. You are a team player with experience with global matrixed organizational structure and posses a global mindset. You are used to working in different time zones.

You are confident and self-assured to enable courage in decisions, and you are a skilled and diplomatic communicator who identifies the necessary people to engage at each stage of the project. Moreover, you are highly motivated and interested in being challenged professionally and you have strong interpersonal skills and a proven ability to communicate with many stakeholders. Finally, you have a high level of organizational skills and attention to details.

Orphazyme offers a unique opportunity in a company with an exciting pipeline and a positive and informal environment. Orphazyme is growing rapidly and the rate of change is high and hence the opportunities to contribute and influence are many.

Travelling: 20 days per year.

Domicile: Ole Maaløes Vej 3, DK-2200 Copenhagen N.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Consultant Belinda Bramsnæs, Unique Human Capital on M: +45 28 44 28 44. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
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