(Senior) Consultant Qualification

About the roleAs a (Senior) Consultant Qualification & Validation, you will play a key role in ensuring compliance and quality within the life sciences industry. You will independently manage and execute qualification and validation activities for equipment, utilities, facilities, computerised systems, and processes, ensuring adherence to GxP standards and global regulatory requirements (FDA, EMA, WHO, ISPE GAMP 5). Acting as a primary contact for clients, you will lead projects from planning to completion, provide strategic guidance, and build strong client relationships. This role requires working on-site at client locations across Germany, providing hands-on support and ensuring successful project delivery.Key ResponsibilitiesIndependently lead validation and qualification activities for equipment, utilities, facilities, computerised systems and processesEnsure high-quality, compliant deliverables according to GxP standards and regulatory requirements (e.g. FDA, EMA, WHO, ISPE GAMP 5)Prepare, review and approve validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols and Validation ReportsTroubleshoot validation-related issues, identify root causes and propose pragmatic, compliant solutionsPrepare, execute and document processes validation for Manufacturing, Labelling and PackagingPrepare, execute and document cleaning validation for Production line and equipment like cleaning, mobile & multipurposeManage project timelines, resources and deliverables to ensure successful project executionAct as the main client contact for validation-related topics, leading client meetings, workshops and project communicationsBuild and maintain strong client relationships, ensuring client satisfaction and identifying additional business opportunitiesMentor and support junior team members in validation best practices, documentation standards and regulatory expectationsContribute to the continuous improvement of validation and qualification methodologies and internal processesLead quality assurance activities within validation projects, ensuring adherence to internal and client-specific quality standardsSupport change management activities related to validation projects, helping clients manage regulatory changes and new technologiesQualifications, Skills and ExperienceEducation & Experience:Bachelor’s, Master’s degree or PhD in Life Sciences, Engineering, Computer Science or a related fieldAdditional certifications (advantageous): e.g. GAMP5 Practitioner3–5 years of hands-on experience in Validation and Qualification within the Life Science industry (e.g. pharma, biotech, medtech)Proven experience leading validation and qualification activities (equipment, utilities, facilities, computer systems, processes)Experience in risk-based validation approaches and knowledge of current regulatory expectations (e.g. FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP 5)Practical experience in authoring, reviewing and approving validation documentation (Validation Plans, URS, IQ/OQ/PQ protocols, Validation Reports)Knowledge, Skills & Competencies:Deep understanding of GxP, data integrity and regulatory requirements across global markets (FDA, EMA, WHO)Demonstrated track record in managing client-facing projects, including client communication and relationship managementAdvanced knowledge of validation project management methodologies (traditional and agile approaches)Proficiency with validation lifecycle management tools (e.g. ValGenesis, Kneat Gx)Strong analytical skills, including root cause analysis and risk assessment in validation contextsAbility to implement digital validation solutions and drive process optimisation initiativesStrong communication and presentation skills, including the ability to lead client meetings, workshops and auditsExcellent problem-solving skills, with the ability to propose innovative, compliant solutionsHigh adaptability to manage change and ambiguity in dynamic project environmentsStrong time management skills with the ability to handle multiple validation projects in parallelStrong self-reflection and continuous improvement mindsetCultural awareness and the ability to work effectively in diverse, international teamsVery good command of English and German