2 days ago Be among the first 25 applicantsGTP Biologics – Olon France, part of the OLON Group, is a contract development and manufacturing organization (CDMO) offering process development and manufacturing services for biotherapeutics (recombinant proteins and antibody-drug conjugates).We are currently looking for a future Quality Director – Qualified Person to join GTP Biologics – Olon France, a human-sized company ( 40 talented experts in the area of employees) located in Saint-Julien-en-Genevois, to help us meet our future challenges.Key ResponsibilitiesAs a Quality Director you work closely with the Company’s CEO and the Quality Director of OLON Grupe and leads the site’s quality strategy, ensuring regulatory compliance and adherence to GMP standards across all activities (development, production, quality control, batch release).You serve as a Qualified Person (QP) / Chief Pharmaceutical officer, ensuring compliance with GMP and ANSM requirements in activities related to Development, Production, and Batch Control of biotechnological products for both clinical and commercial phases. As Qualified Person you are responsible for maintaining the pharmaceutical establishment, and the batch certification and release of finished products.You supervise the Quality Assurance and the Quality Control teams.You are the primary point of contact for clients and health authorities on all quality-related matters. Together with your team, you prepare, conduct, and successfully manage clients’ audits and inspections (ANSM, EMA, FDA, etc.) and manage non-conformities, deviations, complaints, OOS, self-inspections, suppliers audits and oversee CAPA plans.You contribute to the continuous improvement of the quality system, team development, and the site’s quality culture.ProfileDoctor of Pharmacy, registered with the Order (section B), authorized to act as Qualified Person / Chief Pharmaceutical officer.Proven experience (minimum 7 years) in pharmaceutical quality within a production site, ideally in a biotechnological CDMO environment.Strong knowledge of quality standards (GMP, ISO, FDA) and regulatory GMP and CMC requirements applicable to biological and sterile products.Demonstrated leadership, rigor, organizational skills, and ability to unite and lead multidisciplinary teams.Fluent professional English is essential.What We Offer:Permanent contract (CDI), managerial status, annual working time arrangement of 213 days with compensatory leave (JRTT)Company health insurance, 1 day of teleworking per week, time savings account (CET), and meal vouchersA dynamic and innovative work environment open to creativity and personal contributions, with opportunities to participate in pioneering projects in a fast-evolving industryAccess to training programs and internal mobility opportunities in line with Olon Group strategyAn inclusive and supportive environment promoting diversity and integration for allSeniority levelDirectorEmployment typeFull-timeJob functionQuality AssuranceIndustriesPharmaceutical Manufacturing
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