US Head of Quality - ITF Therapeutics LLC

Title: US Head of Quality

Location: Concord, MA, Remote

Reporting to: Chief Operating Officer

About the Company

ITF Therapeutics is the U.S.-based rare disease division of Italfarmaco S.p.A., a private multinational group headquartered in Milan, Italy. Established in 1938, its mission has been to improve patient lives and overall well-being through pioneering research & development, high-quality production, and global marketing of branded prescription and non-prescription products. Operating in the pharmaceutical and API development, Italfarmaco Group has a presence in over 90 countries, employs 3,800 individuals, including 300 professionals across its four Research & Development Hubs, and generates a turnover exceeding 1 billion Euros. The group is known for its products in key therapeutic areas such as Women's Health, Neurology and Psychiatry, Cardiovascular and Metabolic, and Rare Disease.

In January 2024, Italfarmaco launched ITF Therapeutics as a new division in the United States with a focus on the development and commercialization of products to treat rare diseases including Duchenne muscular dystrophy (DMD), a rare and severe form of muscular dystrophy. Highlighting this commitment, ITF Therapeutics successfully secured FDA approval in March 2024 for Givinostat, the first nonsteroidal medication approved to treat all genetic variants of DMD in patients six years of age and older. Givinostat is a histone deacetylase (HDAC) inhibitor that has shown potential in reducing inflammation and fibrosis in muscles, thereby slowing the progression of the disease. Building on a legacy grounded in collaboration and innovation, ITF Therapeutics strive to partner with leaders from the U.S. patient advocacy and treatment communities to ensure that our programs reflect and support their unique needs and goals. The establishment of ITF Therapeutics also reflects Italfarmaco’s goal to build a world-class team of experts that share a passion to make a positive impact for rare disease communities.

The Role

The US Head of Quality will oversee the Quality Management System (QMS) and guide the organization toward continuous quality improvement. The Head of Quality will manage the quality function, ensuring alignment with organizational goals, compliance, and innovation in quality practices.

Primary Responsibilities:

• Define quality objectives and create a strategic plan for implementation specific to US quality operations.
• Collaborate with regional and global quality functions to develop and implement a unified quality strategy.
• Lead QMS development, aligning quality efforts with organizational goals and driving continuous improvement.
• Develop and implement a QMS from a paper-based system to an electronic based quality system.
• Create and adapt annual quality plans based on goals, audits, and feedback.
• Plan and manage audits, inspections, and follow-ups to maintain standards.
• Oversee quality issues, including deviations, complaints, recalls, and CAPA, ensuring regulatory compliance.
• Develop and implement SOPs.
• Communicate quality metrics and progress to senior management and stakeholders.
• Manage the quality budget for efficient resource allocation.
• Integrate industry trends and innovative quality practices.

Required Skills:

• 8-10 years of experience working in Quality with significant prior QMS oversight within a regulated environment (pharmaceutical or biotechnology industry).
• Strong leadership and team development abilities.
• Expertise in QMS and eQMS implementation; experience with Pragma is preferred.
• Expertise in Quality and regulatory compliance
• Proven experience in audits, inspections, and CAPA management.
• Experience collaborating with and leading contract manufacturers and working with external vendors.
• Excellent communication and stakeholder management skills.
• Budget management and resource allocation expertise.
• Commitment to continuous improvement and quality innovation.
• Travel to two offshore sites once a quarter is expected.

This role offers an exciting opportunity to be a key player in a growing organization dedicated to making a significant impact in rare disease treatment.