Job DescriptionDirector Quality
This can be a great opportunity for someone with vast experience in a GxP environment within the Biotech or Pharma Industries. If you are looking for an environment where your ideas will be taking in consideration and actually implemented while working with people that are truly dedicated to make a difference then this is the right opportunity for you. You will be shaping a quality system and department from concept to implementation in this Senior appointment.
The Director of QA will design, implement and maintain QA by establishing quality plans, policies and will report to the Senior Management. The person will establish, maintain, ensure quality programs, SOP system, training program, conduct internal and external audits and will assure compliance in a GxP international environment.
- Lead the implementation of the distribution network for the commercial product
- Quality leadership for the market expansion outside of EU
- Design and maintain Quality Assurance and GxP (GMP, GDP, GCP) compliance for all aspects of company programs to support product registration, launch and future clinical activities
- Oversee compliance auditing program to fulfill regulatory requirements
- Provide GxP Quality Assurance oversight of vendors and maintain quality agreements
- More than 15 years of relevant and current work experience in Biotech/Pharmaceutical industry in Quality Assurance
- Solid and demonstrable knowledge of international GxP regulations (GMP, GDP, GCP) and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment
- Experience of guiding a company through successful approval process
- Work experience in a corporate role
- Master’s degree or PhD with focus in Life Sciences, Engineering or other similar technical field
- Very good knowledge in English
Experience within the EU is needed. Please note we can only accept applications from candidates who hold valid European Union passport and are able to work in Europe without visa sponsorship.
For a confidential discussion about quality assurance then send your CV to firstname.lastname@example.org.