Job Purpose
The role of the Head of Validation and Compliance is to lead and manage all validation and compliance activities related to equipment, facilities, and utilities at a pharmaceutical manufacturing site.
This involves ensuring that validation strategies are in alignment with regulatory expectations and internal quality standards, and that they effectively support ongoing operations and project initiatives.
Key Responsibilities:
* Develop, maintain, and ensure the implementation of the Validation Master Plan (VMP) for equipment and utilities.
* Oversee the validation lifecycle (IQ/OQ/PQ) of process equipment, utilities, and critical systems (e.g., HVAC, WFI, clean steam, compressed air).
* Manage the Compliance & Validation team, planning resources to support both routine operations and strategic project-based activities.
* Ensure alignment with GMP, FDA, EMA, and ICH guidelines, and proactively prepare for audits and inspections.
* Coordinate validation activities with cross-functional teams, including Engineering, Production, Quality Control, and QA.
* Evaluate and approve change controls and deviations impacting validation status.
* Establish and monitor relevant KPIs and metrics to ensure continuous improvement and risk-based validation approaches.
* Act as the validation SME (Subject Matter Expert) during internal and external audits.
* Lead training and development plans for the validation & compliance team.
* Collaborate with project managers to define validation deliverables for new equipment, process changes, or site expansion.
Required Qualifications & Experience
* Degree in Engineering, Pharmacy, Chemistry, or related scientific discipline.
* Minimum 8–10 years of experience in pharmaceutical validation, with at least 3 years in a leadership role.
* Solid knowledge of EU GMP, FDA CFR 21 Part 11, Annex 15, GAMP 5, and validation best practices.
* Experience with aseptic/sterile production, preferably in respiratory devices and biopharmaceuticals.
* Demonstrated experience in equipment and utilities validation, including HVAC, purified water systems, and clean rooms.
* Strong understanding of risk management methodologies (e.g., FMEA, QRM).
Languages & Technical Skills
* Proficiency in English (written and spoken).
* Validation protocols and lifecycle management (IQ/OQ/PQ).
* Compliance with global regulatory standards.
* Data integrity principles and computerized system validation (CSV).
* Deviation and change control management.
* Project management and resource planning tools.
Soft Skills
* Strong leadership and team development capabilities.
* Excellent communication and interpersonal skills.
* Problem-solving mindset and ability to work under pressure.
* High attention to detail and organizational skills.
* Strategic thinking with a proactive, hands-on approach.
* Cross-functional collaboration and stakeholder management.