Job DescriptionHead of Quality Assurance - Biotech Industry
My client is an emerging innovative biopharmaceutical company that is commercializing treatment against nervous diseases; by joining my client you will directly contribute to help these people in needs. They are now taking one of their products on the market meaning that this is an exciting time for you to join the team. They are looking for a Head of Quality Assurance who will act as a Responsible Person. In this function you will play a role in the commercial area and you will be one of the decision makers by providing input in form of schedules, quality plans, and budgets.
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.
This company was born from a collaboration of various partners and supported by international investors. Due to a small company setting you will benefit from a fast decision making path giving you the chance to see the results of your work in a shorter period compared with big organizations.
The head 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.
- 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
- Conducts activities required as Responsible Person (RP) in Switzerland as related to business
- 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 email@example.com.