· Ensure GMP compliance of products manufactured and/or tested at a contract facility.
· Ensure all aspects of product manufacturing and/or testing are reviewed versus established quality standards and the applicable marketing authorizations.
· Manage quality systems, e.g. change control, deviations, complaints, and product investigations.
· Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished product meet Sanofi and GMP requirements.
· Contribute to the completion of milestones associated with specific projects.
· Ensure that batch release of product is performed in accordance with approved specifications and procedures.
· Support the Qualified Person in any GMP aspects related to batch release of product, as applicable
· Monitor contractor compliance via GxP documentation review and on-site visits/audits.
· Implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
· Compile data and write summaries for periodic product reviews, investigations, complaints, and deviations.
· Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
· Interact with multi-functional internal and external project teams to ensure compliance.
· Respond to technical and quality issues and handle schedule and/or process-related conflicts.
· Demonstrate understanding of applicable EU, US and global regulations related to manufacture of drug substances and medicinal products (small molecules and biologics).
· Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.
· Provide guidance and training to staff as Subject Matter Expert, as applicable.
· May assist in vendor selection and evaluation.
· Provide QA project manager support for change controls and other projects.
· Support the development and management of Quality Agreements between Sanofi and the contractor.
· Participate in contractor quality audits and verify any actions taken by the contractor in response to audit observations are completed satisfactorily if needed.
· Support program for maintaining performance metrics.
· 25% domestic/international travel.
Requirements & Qualifications
· Master’s degree with scientific background and 4 years of experience in a GxP or other regulated environment, to include 2 years in a Quality role.
· Bachelor’s degree with scientific background or equivalent and 6+ years of experience in a GxP or other regulated environment, to include 4 years in a Quality role.
· In-depth understanding of quality systems and current quality management tools.
· Broad knowledge of EU/US GMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory affairs.
· Experience in Quality Assurance with focus on product release within a complex supply chain.
· A working knowledge of biotechnological manufacturing operations, aseptic processing, validation principles, Quality Control techniques and testing methodologies of drug substances and medicinal products is beneficial.
· Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.
· Attention to detail and good organizational skills.
· Strong written and verbal communication skills and the ability to multi-task effectively.
· Problem solving and technical writing skills.
· Fluent in German and English.
· An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
· An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
· An individual and well-structured introduction and training of new employees.
· You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
· As a globally successful and constantly growing company, Sanofi provides international career paths as well.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
At Sanofi diversity and inclusion are foundational to how we operate and are embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize that to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.