- The Director Quality will build and hire the quality organization, be part of the Site Leadership Team and equally serve as a member of the International Quality Organization.
- The Director Quality has the responsibility for the local implementation of the global company quality systems at the Site through current state of construction through commissioning, validation, application for manufacturing license, regulatory approval and into daily GMP operations.
- The Director Quality has the overall responsibility to ensure the requirements of the Quality System Regulations is effectively established and maintained and is to ensure a Responsible Person for the Site is appointed when necessary.
- The Director Quality will be responsible for ensuring that the site is GMP ready as per project schedule.
- This will include, but is not limited to: batch release, maintaining Site Master File, Quality point of contact for technology transfer, responsible for site management review, host of audits and inspections, effective liaison to the corporate quality functions (internal and external auditing, regulatory intelligence, documentation control, training, exception and CAPA management).
- The preferred candidate holds a University degree, preferable Ph. D in a field of Science and has +15 years relevant experience within pharmaceutical or biotech manufacturing environment
- Experience with Site Operations is required
- Strategic decision maker with demonstrated ability to work autonomously and to lead project teams in a matrix organization.
- Dual Language preferred with a preferences for German and English.
- Prior experience with facility construction and start-up strongly preferred.
- Flexibility to frequent international travel during the first two years of employment (up to 30% at times), periodically thereafter.
- Must have proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems.
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
- Experience in drug substance (or API) and drug product are preferred.
University degree, preferable Ph. D in a field of Science
- Our company is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases.
- Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
- Founded in 1978, our company is one of the world’s oldest independent biotechnology company.
- Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options.
- These include programs for secondary progressive MS, Alzheimer’s Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.
- With more than 7,500 people worldwide, our company is truly a global organization.
- Our international operations are based in Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark.
- We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
- All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.