Sr Associate I, Quality Assurance - Switzerland
- The main responsibility of the Sr. Associate I, Compliance is to serve as site liaison to global functions for documentation and training.
- The Sr Associate I should also give support in the implementation of corporate quality systems e.g. change control, CAPA and exception management.
- The Sr. Associate I will also serve as quality point of contact for documentation and training for project managers for other line functions and ensure quality commitments are delivered on time.
- Therefore some experience with project management will be an advantage.
- The Sr. Associate I, Compliance will ensure and lead selected activities to ensure the local implementation of our company global quality systems at the Site such as documentation and training through current state of construction through commissioning, validation, regulatory approval and into daily GMP operations. The realization of these deliverables will culminate in an overarching Quality Plan specific to the operations of the new site.
- The Sr Associate I will also work with global quality department to ensure capabilities and implementation of quality systems under his responsibilities.
- The Sr Associate I should give support to other implementation of quality systems as identified/needed.
- As a consequence of the above job activities will among other things include mapping and gap analyses of the quality management system for operational readiness, authoring procedures or policies and facilitating site management reviews and maintaining the site Master File to eventually ensure full GMP compliance and readiness for regulatory inspections.
- This role is expected to be cross-functional between the Luterbach Quality and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments.
- As such, the position is expected to have expert level knowledge of Quality System operations and business processes within a GMP Biotech environment.
- Previous experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage.
- As the facility is designed to be a high-throughput facility it will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements.
- Drive timeline activities to support the readiness of the quality systems under his responsibilities and supporting business processes for the start-up of GMP production in Luterbach.
- Design, review and maintain related topic of quality plan for the Luterbach site to ensure site GMP readiness as per project timeline.
- Represent Luterbach Quality within the global quality organization to ensure local implementation of the global QMS under his responsibilities
- Responsible for managing the Quality training and system for documentation are in place and maintained
- Act as support for the implementation of operational Quality systems
- Approximately 7 plus years of experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.
- This position will require frequent international travel during the first two years of employment (up to 20% at times), periodically thereafter.
- Dual Language preferred with a preferences for German and English.
- Prior experience with facility construction and start-up strongly preferred.
- Must have proficiency with the Quality systems and business processes associated with automation and integration of testing and production systems.
- Demonstrated ability to work autonomously and to lead project teams in a matrix organization.
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- Strong presentation and organizational skills
- Demonstrated problem solving skills
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
- Candidates with experience in drug substance (or API) and drug product are preferred.
Master degree in Life Science or Technical discipline
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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