QA Director

Posted 03 May 2022
ArbeidstedFornebu
Job type Fast
KategoriFarmasi og legemiddel
ReferenceBBBH531294_1651582005

Job description


SoftOx Solutions AS is a Norwegian BioTech company registered at Euronext Growth Oslo. The company's vision is "Helping The World Fighting Infections" by developing new ways of battling infections and antimicrobial resistance. SoftOx works to fight threats towards human health, including the fight against multiresistant bacteria (AMR), biofilm infections in chronic wounds, and the spread of viruses.

For more information about SoftOx, visit https://soft-ox.com/

We are growing and are looking for QA Director

Our Quality Assurance Director will manage all QA Functions and work across all our departments to deliver QA leadership and be a main contributor to Soft-Ox in our pursuit to deliver high quality products in a timely fashion. You will be responsible for maintaining and developing our quality system and ensure that our methods, processes and procedures conform to internal guidelines as well as regulatory standards.

This is an opportunity for a highly motivated and skilled person to work in a fast-paced organisation contributing to sustainable solutions for the hand disinfectants and drugs to make an impact on world health.

Main tasks and responsibilities:

  • You will manage the QA Systems
  • You will manage all the quality systems for the site.
  • You will provide trainings in GMP and relevant topics.
  • You will manage QMS reporting and -review.
  • You will manage the GMP self-inspection program for the plant, plus participation as inspector.
  • You will host and coordinate inspections by regulatory bodies or third-party customers
  • You will manage and support establishment, approval and authorisation of regulatory and GMP documentation.
  • You will lead the QA/GMP team. You will contribute to develop strategies, priorities and procedures within relevant areas of Quality Assurance.
  • You will act as a coach and leader for employees and support other managers at the Plant in GMP and Quality Issues.
  • You will contribute to preparation and review of annual Product Quality Review You will report for all products and Annual Reports for products marketed in US.
  • You will actively apply LEAN methodology to standardize processes and Risk Management tools to identify root-causes for negative trends and failing processes plus implementation of CAPA.
  • You will be responsible for EHS compliance in QA Systems and support in relevant EHS processes at the site


We believe you have the following background:

  • Master's degree or higher within Science or Pharmacy.
  • This role requires significant experience in Quality operations. Extensive cross-functional experience from the pharmaceutical industry in Manufacturing/Quality Control/Quality Assurance/Technical Operations/ R&D activities.
  • Broad competence in quality management, international pharmaceutical regulations and standards within the GMP area.
  • Strong oral and written communication skills in both Norwegian and English.
  • The role requires physical attendance at the Fornebu site


Qualities we are looking for in our new colleague:

  • Strong interpersonal and leadership skills.
  • High performance in the behaviours of leading with transparency, delivering with focus and acting with humility
  • Demonstrated ability to analyse and resolve problems.
  • Demonstrated ability to lead program / projects



We can offer you this:
An exciting role in a Norwegian start-up company, with ample opportunity to take part in building up a company and leave an impact. Challenging and varied tasks in an informal and creative organization. Competitive salary and benefits.

For questions regarding the position, please contact Kelly Life Science, Consultant Ingvild Ringen on +47 988 04 308 or Branch Manager Thomas Lund on +47 401 08 070. Kelly Life Sciences is a recruitment agency, specialized in positions in the Life Science Industry in Norway.

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