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.

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- 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 xysqume 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