Global Validation & Compliance Lead (Remote-Friendly)

Chiesi Group; Parma; Híbrido; EUR 52.000 - 65.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Descripción de la vacante

Chiesi Group, Parma-based global biopharmaceutical leader, seeks a senior leader to drive validation, qualification, data integrity and regulatory compliance across manufacturing and lab ops. You will lead the site validation lifecycle, ensuring GMP compliance and robust quality systems.

Responsibilities include budgeted project oversight, team leadership, risk-based decision making, and collaboration with EHS and Quality to sustain excellence at the Parma facility.

Formación

• Bachelor’s or Master’s Degree in a scientific or engineering discipline (e.g., Chemistry, Pharmaceutical Chemistry and Technology, Engineering).
• Minimum 8–10 years of experience in pharmaceutical or biopharmaceutical manufacturing environments, within Engineering, Production, Process Technology, QA Validation, Technical Services or Quality Assurance functions.
• Extensive experience in validation and qualification of equipment and systems within cGMP-regulated environments.
• Strong knowledge of EU and FDA regulatory requirements, with direct exposure to regulatory inspections (e.g., FDA/DEA).
• Proven background in managing validated/qualified systems.
• Strong capability to define and execute strategies to effectively manage multiple projects simultaneously.
• Solid technical problem-solving skills, with the ability to assess risks and implement balanced, compliant solutions.
• High level of initiative, accountability, and decision-making ability, with capacity to work effectively with minimal supervision.
• Excellent teamwork and interpersonal skills, with the ability to build constructive relationships across all organizational levels.

Responsabilidades

• Oversee validation and qualification activities by defining objectives and timelines, reviewing data, and identifying necessary corrective actions.
• Collaborate to the site equipment lifecycle management, ensuring proper execution of qualification, maintenance, and calibration plans.
• Perform QA review and approval of validation documentation throughout the equipment/instrument lifecycle (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV).
• Support investigations of qualification deviations, identifying appropriate corrective actions and assessing regulatory and operational impact.
• Manage environmental validation activities and cleaning validation programs for manufacturing facilities.

Conocimientos

Data integrity

Regulatory knowledge

Project management

Leadership

Cross-functional collaboration

Quality systems

Educación

Bachelor’s or Master’s Degree in a scientific or engineering discipline

Herramientas

Validation & qualification processes

cGMP regulatory knowledge

Descripción del empleo

Chiesi Group, Parma-based global biopharmaceutical leader, seeks a senior leader to drive validation, qualification, data integrity and regulatory compliance across manufacturing and lab ops. You will lead the site validation lifecycle, ensuring GMP compliance and robust quality systems.

Responsibilities include budgeted project oversight, team leadership, risk-based decision making, and collaboration with EHS and Quality to sustain excellence at the Parma facility.