Director Quality Assurance

A key role in setting direction and managing quality assurance for commercial and pipeline products

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MC2 Therapeutics is a privately held commercial-stage pharmaceutical company committed to research in skin biology and the development of novel treatment paradigms for people with autoimmune and chronic inflammatory skin conditions.

The Director Quality Assurance will report to the CEO. You will work closely with the COO and the rest of the team to ensure that ongoing activities are in compliance with current GxP regulations and that MC2 Therapeutics’ Quality Management System (QMS) is compliant.

You will be responsible for oversight of commercial and pipeline products from a quality assurance perspective, including audit planning, complaint/recall management, as well as handling deviations, change controls, and out-of-specification reports. You will further be involved in vendor oversight.

Your main tasks are:

• Ensure company compliance to relevant good manufacturing practices (GMP) and good distribution practices (GDP) regulations
• Depending on profile and experience involvement in good clinical practices (GCP) and good pharmacovigilance practices (GVP) activities
• Development and management of QMS according to current regulations and requirements, including drafting and implementation of QMS documents/standard operating procedures
• Ensure consistent GxP vendor oversight across the organization
• Planning of GMP, GCP, and GPV audits. Including follow-up and concluding as appropriate
• Lead preparation and conduct of GxP authority inspections and partner audits
• Complaint and recall handling for commercial products in collaboration with partners where relevant
• Handling of deviations, change controls, and out-of-specification reports in collaboration with external vendors where relevant
• Quality assurance responsibility for the release of drug products for the US market in compliance with NDA
• Drive and set the agenda for continuous maintenance and implementation of a quality assurance mindset in the organization

Your qualifications include the following:

• MSc in Pharmaceutical Sciences or similar
• 5-10 years of relevant quality assurance experience in the pharma/biotech industry
• Thorough understanding of good manufacturing/distribution practices US and EU (GMP/GDP). Certification as qualified person is not a requirement
• Knowledge of GCP and GVP regulations
• Experience with audits and/or inspections
• Ability to work independently with multiple tasks and good collaboration skills internally and with external vendors

You are proficient in English and Danish at a professional level, both written and spoken, and you master MS Office.

You are a person who is self-driven, able to take responsibility for your own projects, and has a natural interest in engaging directly in quality-related matters. It is crucial that you are proactive and can work independently and set the direction. You have strong collaborative skills and can create successful working relationships with both internal and external stakeholders. You are systematic and organized in your way of working and set high-quality standards with an eye for detail.

MC2 Therapeutics offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to MC2 Therapeutics’ strategy and work together with highly skilled and experienced colleagues to advance their exciting product pipeline.

 Traveling: 5 – 15 days/year

Domicile: Hørsholm, North of Copenhagen

For more details about the job or the company, please contact Research Consultant, Caroline Krüger, Unique Human Capital, on M: +45 51 21 99 33 or E: [email protected]. All applications must be in English and are treated confidentially.