Overview In this role you oversee site validation and qualification activities to ensure products meet quality standards within GMP guidelines. You provide regulatory-aligned oversight across equipment, processes, utilities, and computerised systems, supporting Data Integrity and CSV governance. You lead risk-based validation strategies, drive continuous improvement, and collaborate with cross-functional teams to sustain safe, compliant operations. This position offers impact in a global manufacturing network and a chance to shape site quality programs. Retribuzione / Benefits
* annual premio
* pension
* private medical insurance
* wellbeing programme
* flexible benefits
* remote work options Responsabilità
* Support Quality Management in budgeting for departmental projects and initiatives
* Contribute to workforce planning by assessing FTEs and required competencies
* Define and maintain internal structure with roles, responsibilities, and job assignments
* Set and align qualitative and performance objectives with the MBO system
* Promote team development through targeted training and coaching
* Ensure personnel alignment with corporate competencies and behaviors
* Monitor compliance with values, code of conduct, ethical standards, and legal/contractual requirements
* Manage personnel in line with labor laws and health and safety regulations; coordinate team activities
* Ensure operational efficiency and safety of departments, facilities, and equipment; oversee maintenance
* Propose investments to maintain safety, compliance, and operational effectiveness
* Ensure mandatory safety training and information dissemination
* Collaborate on departmental Risk Assessment Document (DVR) updates
* Implement risk controls and emergency procedures
* Ensure proper use of PPE and timely replacements
* Report irregularities posing health and safety risks
* Oversee Validation Project Plans (VPP) and Validation Final Reports (VFR) development
* Supervise Technology Transfer documentation for regulatory compliance




* Lead validation/qualification activities with objectives and timelines; review data and corrective actions
* Coordinate equipment lifecycle management; qualification, maintenance, calibration
* QA review of validation docs (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV)
* Investigate qualification deviations and assess regulatory impact
* Manage environmental and cleaning validation programs
* Ensure GDP-compliant pharmaceutical transport validation
* Support new site projects with regulatory-aligned validation strategies
* Contribute to process verification planning and documentation
* Coordinate CSV and Data Integrity review activities
* Support risk assessments to define CPPs/CQAs and validation strategies
* Coordinate cross-functional risk assessments for regulatory submissions
* Collaborate with Production to align GMP and production plans
* Support CAPA from audits/inspections; participate in self-inspections and audits
* Maintain Validation Master Plan and Validation Change Control Program
* Act as SME for process validation topics; deliver training on Validation processes
* Drive continuous improvement to streamline validation and reduce non-value-added activities
* Provide leadership for validation-related CAPA activities
* Participate in Quality Risk Management and FMEA activities as Validation SME Requisiti fondamentali
* 8–10 years of experience in pharma or biopharma manufacturing
* Extensive experience in validation and qualification of equipment and systems in cGMP environments
* Strong knowledge of EU and FDA regulatory requirements; exposure to regulatory inspections (e.g., FDA/DEA)
* Proven track record managing validated/qualified systems
* Ability to define and execute multi-project strategies
* Solid technical problem-solving and risk assessment skills
* High initiative, accountability, and ability to work with minimal supervision
* Excellent teamwork and interpersonal skills across organizational levels
* leadership
* team collaboration
* communication
* Validation, Qualification & Compliance
* GMP
* CSV (Computerised System Validation)

📌 Validation & Equipment Compliance Manager (Parma)
🏢 Chiesi
📍 Parma