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Director of Quality Assurance/QP, SmartPractice, Hillerød

SmartPractice Denmark develops, manufactures and distributes innovative patch testing medicinal
products, ancillary supplies, and world class customer support and education. SmartPractice is the global
market leader for contact allergy patch testing, everyday living the motto “because patients deserve a
diagnosis”.
SmartPractice’s 45 employees are located in Hillerød. They are now looking for a Director of Quality
Assurance/QP to lead, manage and develop the QA area across the organization for present and pipeline
products and processes. The position reports to the President of SmartPractice Denmark, and offers great
influence and opportunities for personal and professional development.

ABOUT THE POSITION

You will be part of the management team, and head the QA department with currently four other highly
skilled, experienced and motivated colleagues.
Your main areas of responsibility will be:

  • Overall planning of objectives and assignments related to QA
  • Handling QA matters related to manufacturing
  • Taking on the QP responsibility
  • Handling distributor/customer issues and inquiries related to QA
  • Management representative concerning Biologic/Device Combination Products
  • Preparing QA documentation and reporting, including approving changes
  • Ensuring that PV tasks are handled by external consultant according to contract
  • Planning and leading external inspections (FDA, LMS, PMDA ..)
  • Keeping staff up to date and well trained in all in- and external procedures and requirements
  • Current review of the effectiveness of the Pharmaceutical Quality System

CANDIDATE PROFILE

As a person you thrive on working with a broad responsibility and keeping multiple balls in the air. A great
working environment is important to you, and you contribute with positivity and a can-do attitude to
create passion and job satisfaction around you.
Further you:

  • Hold a Master’s Degree in Pharmacy and have worked as a QP or QP Deputy
  • Have people management experience from Pharma or Medtech
  • Possess great presentation skills both orally and in writing in English and Danish

APPLICATION

Feel free to call Lotte Tolstrup, Search & Selection Group (cell 40329734) for further information.
Candidates are interviewed continuously, therefore please submit your application as soon as possible to
Lotte@s-sgroup.dk. Regarding GDPR, please refer to our web site s-sgroup.dk/gdpr-english/

ABOUT THE COMPANY

SmartPractice Denmark is owned by SmartPractice US, please see www.smartpractice.com. Flagship
product is the T.R.U.E. TEST® (T.R.U.E. short for Thin-layer Rapid Use Epicutaneous), which is the only FDA
approved patch testing product for diagnosing allergic contact dermatitis. Through investments in
technology, clinical science, and world-class service, SmartPractice is committed to assist patients and
doctors to diagnose allergic contact dermatitis worldwide.

Adresse

  • SmartPractice Denmark ApS Herredsvejen 2
    DK-3400 Hillerød
  • +45 4820 7100
  • 89669510

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Location

SmartPractice Denmark is located in Hillerød, 35 km north of Copenhagen in beautiful surroundings near the Frederiksborg Castle.

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