Validation & Equipment Compliance Manager
Pubblicato il 09-10-2026 - Chiesi in Parma
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)