Director, Quality Operation

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

Director, Quality

Pharma Services Group (PSG) – Drug Product Division

Location: Ferentino, Italy site

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day to enable our customers to make the world healthier, cleaner, and safer.

We provide our teams with the resources, leadership, and opportunities needed to achieve their career goals while helping to take science a step beyond. From accelerating drug development to supporting life-changing therapies, our work directly impacts patients worldwide.

The Opportunity

We are seeking an experienced and strategic Director of Quality to join our Pharma Services Group (PSG) Drug Product Division at our Ferentino manufacturing site.

As a key member of the Site Leadership Team, you will provide leadership and direction for Quality Operations, Compliance & Batch Release activities. You will ensure the highest standards of product quality, regulatory compliance, and inspection readiness while supporting the continued growth of one of Thermo Fisher Scientific’s most important pharmaceutical manufacturing sites.

This role offers the opportunity to partner closely with customers, regulatory authorities, corporate quality leadership, and operational teams to drive a culture of quality excellence, continuous improvement, and operational performance.

Key Responsibilities

Quality Leadership & Compliance

• Provide strategic leadership for Quality Operations, Compliance & Batch Release,
• Ensure ongoing compliance with cGMP, FDA, EMA, MHRA, and other applicable regulatory requirements.
• Maintain a state of inspection readiness and successfully lead regulatory inspections and customer audits.
• Act as the primary quality representative for critical compliance matters and quality-related business decisions.

Quality Operations & Product Release

• Ensure timely disposition and release of products through effective management of quality systems and batch certification processes.
• Provide oversight of investigations, deviations, CAPAs, change controls, complaints, and risk management activities.
• Support Qualified Person (QP) activities and ensure robust product lifecycle quality oversight.
• Drive effective quality review and escalation processes to proactively identify and mitigate risk.

Customer & Regulatory Engagement

• Serve as a trusted quality partner to customers, regulatory agencies, and corporate stakeholders.
• Lead customer quality governance meetings and manage quality agreements.
• Support regulatory submissions, inspections, and responses to regulatory observations.
• Provide strategic guidance during customer onboarding, technology transfers, and commercial product launches.

Continuous Improvement & Operational Excellence

• Drive continuous improvement initiatives across manufacturing, laboratory, and supply chain operations.
• Utilize quality metrics and performance indicators to identify trends and opportunities for improvement.
• Champion quality culture, digital transformation initiatives, and operational excellence programs.
• Promote proactive risk management and data-driven decision making throughout the organization.

Leadership & Talent Development

• Lead, coach, and develop high-performing quality teams.
• Build organizational capability through succession planning, talent development, and employee engagement.
• Foster a culture of accountability, collaboration, and continuous learning.
• Partner effectively across Operations, Technical Services, Supply Chain, Engineering, and Corporate Quality functions.

Minimum Qualifications

• Advanced Degree with 6+ years of experience, or Bachelor’s Degree with 8+ years of experience in a regulated pharmaceutical, medical device, biologics, diagnostics, or related industry.
• Degree in Life Sciences, Engineering, Chemistry, Pharmacy, or related scientific discipline.
• Minimum 5 years of leadership experience within Quality organizations.
• Strong working knowledge of cGMP requirements, FDA regulations, EU GMP guidelines, and global quality standards.
• Proven experience leading regulatory inspections and customer audits.
• Demonstrated expertise in Quality Systems, CAPA, investigations, change control, risk management, and batch disposition.
• Experience managing customer relationships and quality agreements.
• Strong leadership, communication, and stakeholder management skills.
• Demonstrated ability to lead organizational change and continuous improvement initiatives.
• Project management, financial planning, and resource management experience.

Preferred Qualifications

• Qualified Person (QP) certification or eligibility preferred.
• Professional certifications such as ASQ, RAPS, or equivalent.
• Experience within CDMO and contract manufacturing environments.
• Experience supporting global customer portfolios and complex supply chains.
• Knowledge of digital quality systems and quality management software platforms.
• Experience working within matrix and multi-site organizations.

Leadership Competencies

• Sets strategic direction and translates vision into execution.
• Builds and develops high-performing teams.
• Creates a culture of quality, compliance, and accountability.
• Influences effectively across functions, customers, and global stakeholders.
• Drives innovation, operational excellence, and continuous improvement.
• Demonstrates strong business acumen and decision-making capability.

Travel

• Up to 30% domestic and international travel may be required.