Headquartered in Lachen near Zurich, Switzerland, the Octapharma Group is a leading company in the worldwide market for therapeutic human proteins. Working at Octapharma means to have an opportunity to contribute to our common goal – developing lifesaving therapies to improve patients’ lives.
We are seeking
a motivated professional to join the corporate Quality organization as the Head of Corporate Quality Assurance. The position reports to the Corporate Quality and Compliance officer. The role will be based in either Vienna, Austria or Stockholm, Sweden alternatively in Springe, Germany; Lingolsheim, France or Lachen, Switzerland.
Your main responsibilities and opportunities
- Ensuring that the pharmaceutical Quality Management System (PQMS) is in compliance with GxP Regulations and guidelines and Octapharma internal rules and guidelines. Responsible for developing, maintaining and harmonizing the PQMS within the Octapharma Corporation.
- Driving the strategic direction of the QA function and support the Heads of QA at manufacturing/packaging sites in all quality subjects and performances to ensure the GxP level at the sites.
- Process ownership for quality processes such as: change controls, deviations, supplier qualification, documentation and procedures, PQR/APR, audits & inspections, GxP trainings.
- Ensuring compliance with regulations and expertise in: GMP, GDP, Directives for combination products and medical devices. Monitoring the current regulations and guidelines
- Acting as the QA-expert at Octapharma with international authorities & international organisations
- System ownership for Trackwise and Libero Manager. Acting as process owner in the electronic document management system and in the electronic learning management system.
- Responsible for harmonisation of Corporate strategies; Product life cycle; Validation and Qualification; Risk Management
- You have a medical science / life science background (university degree) focusing on Chemistry, Biochemistry, Biotechnology, Chemical Engineering or Pharmacy, alternatively business education with strong background in pharmaceutical business.
- You have previous 10 years of working experience in the pharmaceutical industry and several years in the quality area.
- You have a deep expertise in manufacturing and distribution of pharmaceuticals.
- You held a management position preferably in global environment.
- You have hands on experience in auditing, ideally worked as lead auditor for several years.
- You have excellent English language skills in oral and written form (German is advantageous, additional languages are beneficial).
- You have extensive knowledge about current GMP (Eudralex Volume 4 and US Code of Federal Regulations), GDP (Good Distribution Practices) and Combination Product regulations and guidelines
- You are a hands on person used to work in specialized teams on strategic projects.
- As an experienced project leader you know how to convince and to motivate your internal and external teams.
- You are a strong team player, internationally oriented, with cultural awareness and sensitivity.
- You are willing to travel (approximately 25+%).
- You have an open-minded, creative, self-motivated and dynamic personality and you are eager to learn.
- Work in an international and dynamic environment where you have opportunities to grow
- Work within a qualified dynamic team where your contribution can make a real difference for the patients worldwide
- An attractive salary and benefits package
How to apply
Please submit your application in English describing your interest, expected salary and enclosing your CV, references and/or recommendation via our career portal.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood.
At Octapharma, our passion drives us to provide new health solutions advancing human life. This is our vision. We thrive as an organisation in which people take ownership, have integrity, demonstrate grounded and confident leadership, drive sustainability, and are inspired by and eager to embrace entrepreneurship.
We employ more than 9 300 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas:
- Haematology (coagulation disorders)
- Immunotherapy (immune disorders)
- Critical care (bleeding management and functional volume replacement)
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, in addition to more than 120 plasma centres across Europe and the US.
For more information visit www.octapharma.com