ITF Therapeutics LLC · 20 hours ago
Senior Manager, Quality Systems
Concord, MA
Full-time
Hybrid
Senior Level
$150K/yr - $175K/yr
6+ years expITF Therapeutics is seeking an experienced Senior Manager, Quality Systems, as a key member of their Quality team. This role is responsible for the continuous improvement of the Quality Management System (QMS) supporting commercial pharmaceutical distribution operations and ensuring compliance with regulatory requirements.
ManufacturingPharmaceuticalTherapeutics
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
Qualification
Required
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
Preferred
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
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
Company
ITF Therapeutics LLC
ITF Therapeutics is the US-based rare disease division of Italfarmaco S.p.A.
51-200 employees
Funding
Current Stage
Growth StageRecent News
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