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Global Head of QA

You will ensure that all processes needed to operate the quality management system are established, implemented and maintained as well as the promotion of awareness of the requirements of authorities and customers throughout the organization. In the position you will be responsible for the Quality Management with the overall objective of ensuring a high-quality standard, reputation and conformity.

With direct report to Global Head of Technical Operations.

Your main tasks are:

  • Forming a sustainable quality culture based on compliance to regulations, patient safety, and continuous improvement of quality processes to benefit the end customers
  • Enhance the quality culture  so people at all levels of the organization speak up when concerns, risks or issues occur so leaders can proactively address them through early mitigation. Embed an  enterprise learning culture  across Orphazyme to ensure that decisions and outcomes are delivered to the best of the highest standards
  • Partnering with the Orphazyme leadership team to drive product quality through critical metrics trend analysis and implementation of improvement initiatives for the total product life cycle
  • Managing the Quality Management Reviews
  • Maintain contemporary knowledge of the  evolving regulatory expectations and global environment that impact the business to proactively manage risks and increase the robustness of the business processes and decision making
  • Driving training, enhancement, and adoption of the QMS framework and tools
  • Providing effective guidance and oversight for quality assurance and regulatory processes, as well as owning key decisions for the total product life cycle
  • Ensuring compliance to existing and applicable global Quality Systems Requirements
  • Translating new industry trends and requirements into business policies and practices
  • Staffing and managing a team of QA professionals with the required skills and experience to execute their job responsibilities
  • Your qualifications are a minimum of 15 years Quality Management/Regulatory Affairs/ manufacturing experience in the Pharmaceutical industry or other regulated industries together with a minimum of 5 years working in a leadership role or similar. Practical experience and a good understanding of product development, manufacturing, quality control and servicing in a pharmaceutical and/or clinical environment is important.

    Moreover, practical experience with handling Regulatory authorities, pre-approval inspections such as FDA, EMA etc. is preferred. You have medical basic knowledge of relevant medical applications and knowledge of products, processes and workflows in the field. Finally, you have good knowledge of relevant national and international directives and regulations i.e. CFR 210 & 211, EMA, ISO Quality systems, PICS, WHO and other relevant quality standards.

    You are a leader who is self-reflective, leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement. You can navigate through ambiguity and rapid growth and are able to adapt to change. Finally, you have a track-record of leading, coaching, and mentoring high-functioning and collaborative teams and you have the ability to constantly learn and challenge status quo.

    You have 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 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 or Grafenauweg 8, Zug, CH-6300 Switzerland.

    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 Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.

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