Group Quality CSV Manager (m/f/d)

Description

Summary: CordenPharma is seeking a Group Quality CSV Manager to ensure compliance with regulatory requirements and optimize GxP IT applications, leading validation strategies and enhancing quality through AI-enabled tools. Highlights: 1. Ensure compliance with GxP IT application lifecycle management 2. Lead evolution and optimization of global validation approaches 3. Identify and implement opportunities to enhance Quality with AI-enabled tools **CordenPharma** is one of the leading Contract Development and Manufacturing Organizations (CDMOs), developing and manufacturing pharmaceutical active ingredients, finished drug products, and related packaging services for its customers as a “full-service” provider. The Group employs approximately 3,000 people. Our network across Europe and the USA offers flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering products of the highest quality for the benefit of patients. **Our People Vision:** We strive for excellence. We share our passion. Together, we make a difference in patients’ lives. **Group Quality CSV Manager (m/f/d)** ===================================== * Lisbon * 01.03.2026 * Full-time * Permanent ### **What you can expect** * Ensure compliance with applicable regulatory requirements, internal Quality standards, and industry best practices for the lifecycle management of corporate GxP IT applications and GxP IT system implementation projects. * Act as a subject matter expert on 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 compliance within the CordenPharma network. * Develop design requirements and validation/testing strategies for electronic business solutions in GxP environments. * Lead the evolution and continuous optimization of global validation and lifecycle approaches, presenting strategies during audits and inspections. * Identify and implement opportunities to enhance Quality, efficiency, and compliance through AI-enabled tools while ensuring adherence to GxP and data integrity requirements. * Supervise cross-functional teams during validation and qualification activities for computerized systems. * Partner closely with Site Quality, IT and Operations teams to implement global computerized systems. * Review and implement IT Quality-related processes, standards, and systems. * Conduct internal and external audits and manage IT service providers to ensure compliance and quality. ### **To successfully master this role, we are looking for the following qualifications:** * Bachelor’s degree in IT, Pharmaceuticals, Engineering, Life Sciences or a similar field. * Profound knowledge of FDA / EU Guidelines, including computer system validation, quality risk management and data integrity. * 2–5+ years professional QA experience in supporting IT applications in a global GxP environment throughout the whole lifecycle of an application, preferred in a CDMO business. * Confident handling with electronic systems, ideally with Trackwise, Labvantage, SAP * Fluent communication in English. * Excellent interpersonal and communication skills. * Highly self-motivated with “Can do” mentality and a strong sense of ownership. * Flexibility and willingness to travel (< 10%). ### **What we offer** #### **Positive working atmosphere and open management culture with focus on continuous improvement of processes to stay innovative** #### **Free Parking** #### **Cafeteria** #### **Health Insurance** #### **Life Insurance** ### **Interested?** If you enjoy working in a team and are interested in a varied scope of responsibilities, if you think beyond your immediate tasks and act beyond your own responsibilities, then you should become part of our team. **CordenPharma does not accept unsolicited applications from recruitment agencies. Resumes submitted without prior agreement will not be considered and do not create any obligation on the part of CordenPharma.** Back Apply