Korn Ferry has partnered with our client on their search for the role,
Senior Qualific & Validation Manager.
Qualification & Validation Manager
Role Summary The Qualification & Validation Manager is responsible for leading the site Qualification and Validation function, ensuring compliance with cGMP requirements across facilities, utilities, equipment, systems, and processes. This role provides strategic direction, oversees validation lifecycle activities, manages a high-performing team, supports audits and inspections, and drives continuous improvement initiatives while balancing compliance, business priorities, and operational needs.
Key Responsibilities Lead the Qualification & Validation function and ensure GMP compliance throughout the validation lifecycle. Develop and implement site validation strategies aligned with regulatory and business requirements. Manage, coach, and develop a team of Qualification & Validation professionals. Act as the site SME during regulatory inspections, customer audits, and corporate assessments. Oversee qualification and validation activities for capital projects, facility expansions, and technology transfers. Manage resource planning, workload prioritization, budgets, and training plans. Review and approve critical GMP documentation, including VMPs, protocols, reports, deviations, CAPAs, change controls, and risk assessments. Drive risk-based validation approaches, governance frameworks, and harmonization of practices across functions and sites. Collaborate closely with Engineering, Manufacturing, QA, QC, Regulatory Affairs, Automation, and Project teams. Lead complex investigations, remediation activities, and compliance improvement initiatives. Monitor departmental KPIs and drive efficiency, compliance, and operational excellence. Promote Lean methodologies and a culture of continuous improvement, safety, and quality.
Required Qualifications Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related scientific field. 8-12 years of experience within pharmaceutical, biotechnology, or other highly regulated manufacturing environments. Significant experience in Qualification & Validation, including lifecycle management of facilities, utilities, equipment, systems, and processes. Demonstrated people leadership and project management experience. Strong knowledge of cGMP, FDA, EMA, ICH guidelines, Data Integrity, and risk-based validation principles. Experience with Engineering, Manufacturing, Quality Systems, Computer System Validation (CSV), Automation, and Facility/Utility qualification. Experience supporting inspections, audits, and regulatory interactions. Fluent English.
Preferred Qualifications Lean Six Sigma certification or equivalent Continuous Improvement experience. Experience managing budgets, strategic projects, and organizational transformation initiatives. Exposure to multi-site or global quality and validation environments.
Key Competencies People Leadership & Talent Development Strategic Thinking & Business Acumen Change Management Stakeholder Management & Influencing Resource & Budget Management Risk Management & Governance Decision Making in Complex Environments Organizational Planning & Prioritization Continuous Improvement Leadership Cross-Functional Collaboration and Matrix Leadership
Ideal Candidate Profile A seasoned pharmaceutical quality and validation leader with strong technical expertise, proven people-management experience, and the ability to influence cross-functional stakeholders. The successful candidate combines deep GMP and validation knowledge with strategic thinking, operational excellence, and the capability to lead teams through growth, change, and regulatory challenges.
Senior Qualific & Validation Manager • Lisbon, Portugal
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