pIn 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.
/p ul liannual premio /li lipension /li liprivate medical insurance /li liremote work options /li liSupport Quality Management in budgeting for departmental projects and initiatives /li liContribute to workforce planning by assessing FTEs and required competencies /li liDefine and maintain internal structure with roles, responsibilities, and job assignments /li liSet and align qualitative and performance objectives with the MBO system /li liPromote team development through targeted training and coaching /li liEnsure personnel alignment with corporate competencies and behaviors /li liMonitor compliance with values, code of conduct, ethical standards, and legal/contractual requirements /li liManage personnel in line with labor laws and health and safety regulations; coordinate team activities /li liEnsure operational efficiency and safety of departments, facilities, and equipment; oversee maintenance /li liPropose investments to maintain safety, compliance, and operational effectiveness /li liEnsure mandatory safety training and information dissemination /li liCollaborate on departmental Risk Assessment Document (DVR) updates /li liImplement risk controls and emergency procedures /li liEnsure proper use of PPE and timely replacements /li liReport irregularities posing health and safety risks /li liOversee Validation Project Plans (VPP) and Validation Final Reports (VFR)



development /li liSupervise Technology Transfer documentation for regulatory compliance /li liLead validation/qualification activities with objectives and timelines; review data and corrective actions /li liQA review of validation docs (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV) /li liInvestigate qualification deviations and assess regulatory impact /li liManage environmental and cleaning validation programs /li liEnsure GDP-compliant pharmaceutical transport validation /li liSupport new site projects with regulatory-aligned validation strategies /li liContribute to process verification planning and documentation /li liCoordinate CSV and Data Integrity review activities /li liSupport risk assessments to define CPPs/CQAs and validation strategies /li liCoordinate cross-functional risk assessments for regulatory submissions /li liCollaborate with Production to align GMP and production plans /li liSupport CAPA from audits/inspections; participate in self-inspections and audits /li liMaintain Validation Master Plan and Validation Change Control Program /li liAct as SME for process validation topics; deliver training on Validation processes /li liDrive continuous improvement to streamline validation and reduce non-value-added activities /li liProvide leadership for validation-related CAPA activities /li liParticipate in Quality Risk Management and FMEA activities as Validation SME /li li8-10 years of experience in pharma or biopharma manufacturing /li liExtensive experience in validation and qualification of equipment and systems in cGMP environments /li liStrong knowledge of EU and FDA regulatory requirements; exposure to regulatory inspections (e.g., FDA/DEA) /li liAbility to define and execute multi-project strategies /li liSolid technical problem-solving and risk assessment skills /li liHigh initiative, accountability, and ability to work with minimal supervision /li liExcellent teamwork and interpersonal skills across organizational levels /li lileadership /li liteam collaboration /li licommunication /li liValidation, Qualification Compliance /li liGMP /li liCSV (Computerised System Validation) /li /ul pValidation Equipment Compliance Manager parma, emilia romagna, it /p #J-*****-Ljbffr

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