Manufacturing Compliance Manager
il y a 12 heures
Manufacturing Compliance Manager – EvotecLocation: ToulouseDepartment: Manufacturing/ProductionReports To: Directeur – Manufacturing OperationsAbout UsJust Evotec Biologics believes curiosity drives innovation and success. We strive to challenge the status quo, learn from each other, and push the boundaries of what’s possible. We are committed to creating an environment where curiosity is celebrated.Are you someone who asks questions, seeks answers, and isn’t afraid to go deeper? #BeCUREious with us and see where curiosity can take you.The Role: Your Challenge… in Our JourneyWe are looking for a passionate and curious Compliance Manager to join our team. If you’re excited by new challenges, solving complex problems, and learning at every step, you may be the right fit. You will drive impactful projects, collaborate with bright minds, and explore uncharted territories. You will have the freedom to ask difficult questions, think outside the box, and find creative solutions that push us forward.What You’ll DoThe Manager Compliance oversees a group of Compliance Specialists and Compliance Support. You will coordinate and manage deviations, changes, CAPAs, and complex projects within production, coordinate and monitor the production schedule, and manage supply and order needs within your group within defined deadlines.Manage and develop the people in your group by identifying training needs to enable autonomous execution of activities.Define and manage budget needs for your group in collaboration with your manager.Apply GMP concepts and harmonized interpretations of regulatory guidance to ensure consistency and compliance across GMP operations.Initiate and follow up on changes with action plans on complex topics/projects in a compliance status and on time.Manage document changes (SOP creation/update, initiation of document changes, etc.).Manage deviations (minor, major, and critical) with appropriate investigation tools/methods, define CAPAs, and implement CAPAs.Participate in audits/inspections, present topics/deviations/changes, evaluate and communicate data/results to auditors/inspectors or clients in French and English. Present and defend records during internal/external audits.Implement and monitor KPIs for production activities; analyze and propose process improvements (SQDCP: Safety, Quality, Deadlines, Cost, People).Develop and implement training programs and materials to ensure that production staff comply with cGMP and achieve high operational competence.Stay current with industry trends, regulatory requirements, and best practices in mammalian cell culture manufacturing processes.Coordinate production activities and preventive/corrective maintenance (MAXIMO).Coordinate with your group on supply needs (raw materials, consumables, equipment), production, and order placement/follow-up.Backup for your manager in their absence.Who You AreMinimum Bac+5 with 4–5 years of people-management experience and 8–10 years in roles linked to the described responsibilities in a cGMP manufacturing environment.Fluent in French and English (written and spoken).Strong knowledge of cGMP requirements.Excellent organizational skills with proven ability to plan and ensure timely execution of activities.Experience leading a multidisciplinary team and managing multiple concurrent activities.Ability to structure and synthesize complex topics.Solid understanding of quality management processes (risk assessments, change controls, deviations, CAPAs, etc.).Analytical skills with ability to identify root causes and develop effective solutions.Excellent communication skills; able to adapt to different audiences.Strong leadership and collaboration skills; able to influence across the organization.Strong decision-making skills in complex environments; attention to quality and detail.Team player with ability to work cross-functionally in a matrix environment.Flexibility to adapt to changing priorities.Experience with single-use technologies used in mammalian cell culture and biopharmaceutical production.Green Belt/Black Belt Lean and/or 6 Sigma certification would be a plus.Why Join UsGrowth opportunities through continuous learning, mentoring, and new projects.Flexible work environment to help balance life and work.Inclusive culture with a diverse and curious workforce.Opportunity to work on innovative projects and cutting-edge technologies.Encouragement of new ideas and constructive input.Are You Still Curious?If you’ve read this far, you likely have a curious mind. Apply today to shape the future of Just Evotec Biologics. Let curiosity guide your career with #BeCUREious.FR: Evotec is an equal opportunity employer and, with equal skills, considers all applicants including people with disabilities.ENG: In the frame of our Diversity policy, Evotec considers all applications including people with disabilities.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionLegal #J-18808-Ljbffr
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Manufacturing Compliance Manager
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