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.
annual premio
pension
private medical insurance
remote work options
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
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
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)
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, emilia romagna, it
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📌 Validation & Equipment Compliance Manager (Parma)
🏢 Chiesi
📍 Parma