Validation & Equipment Compliance Manager

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 bonus
• 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