Senior Manager, Quality Systems

ITF Therapeutics • Concord, MA

36d • Hybrid

About The Position

ITF Therapeutics is seeking an experienced Senior Manager, Quality Systems. As a key member of our Quality team, you will be responsible for continuous improvement of the Quality Management System (QMS) supporting commercial pharmaceutical distribution operations.
Working with closely with internal partners, stakeholders, and external vendors, this role ensures compliance with U.S. and global regulatory requirements, including FDA regulations, Good Distribution Practices (GDP), and DSCSA, while enabling efficient, compliant, and scalable distribution operations.
Reporting to the Head of Quality, you will own and lead multiple key initiatives as our team continues to grow and scale in a fast-paced environment.
This role will be hybrid, so candidates applying must be willing and able to be onsite in our office in Concord, MA 3 days per week on average, in addition to any time or travel according to business needs.

Requirements

• 6+ years of related and progressive experience in pharma/biotech Quality
• Computer system validation experience
• Strong working knowledge of GDP, FDA regulations, and DSCSA requirements
• Experience with implementing and administering an eQMS, eDMS, or eLMS
• As a life science quality professional, you have an eye for detail and understanding of the collaboration and teamwork needed to support commercial excellence.
• You understand how quality helps the business succeed while keeping compliance and patient safety front and center.
• You’re comfortable in a fast-paced, start-up environment, like finding better ways to do things, and feel motivated by knowing your work makes a real difference for patients every day.

Nice To Haves

• Advanced degree a plus
• Experience in related pharmaceutical QMS roles
• Proven ability to establish productive collaborations with internal partners, stakeholders, and external vendors
• Ability to provide subject matter expertise regarding QMS implementation and administration
• Strong working knowledge of integrating a risk-based quality management approach
• Supply chain and distribution expertise
• Experience supporting regulatory inspections and audits in a distribution environment
• Experience with temperature-controlled logistics, warehousing, and 3PL oversight
• Strong experience with metrics and performance indicators
• Data-driven decision making
• Strong organizational skills and attention to detail
• Excellent verbal and written communication skills, with strong presentation capabilities
• Demonstrated ability to work with minimal supervision and manage multiple priorities in a fast-paced environment

Responsibilities

• Own and oversee the enterprise QMS, including deviation, CAPA, change control, product complaints, QMR, Quality Risk Management, and BCP programs
• Serve as the business administrator for the eQMS, including user management, change control, and related computer system validation requirements
• Lead quality governance forums, management review meetings, and escalation processes.
• Provide subject matter expertise to enhance the QMS
• Develop and improve related procedures
• Define, monitor, and analyze quality system KPIs (e.g., deviation trends, CAPA effectiveness, complaints trending, and audit findings)
• Drive continuous improvement initiatives using root cause analysis and corrective/preventive action frameworks
• Leverage data and metrics to proactively identify systemic risks and improvement opportunities
• Maintain inspection readiness through periodic internal audits, gap assessments, and quality health checks
• Develop and implement oversight tools, including related communication
• Create best practices for authoring technical investigations, root cause analysis tools, and corrective and preventive actions
• Meet with QMS record owners and participants to ensure proper system usage
• Support internal and external audits related to the QMS
• Enhance the Quality Culture by serving as a proactive, professional resource for the business

Benefits

• Medical, Dental & Vision Insurance: Nationwide coverage with flexible plan options tailored to your needs
• 401k Company Match
• 100% Paid Bonding Leave: Dedicated time to support growing families
• Disability & Life Insurance: Multiple coverage options to protect what matters most
• Professional Development: Ongoing opportunities to grow your skills and career
• Flexible Time Off Package: Recharge and refresh with generous paid time off
• Additional perks to support your well-being

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed