Senior Manager/AD, Quality Assurance

Company Description

Elion Therapeutics is a biotechnology company that specializes in developing innovative treatments for life-threatening invasive fungal infections. With a team boasting over 200 years of collective expertise in antifungal drug development, Elion is dedicated to pioneering solutions for the treatment of invasive fungal infections and is uniquely positioned to advance therapies that address critical unmet needs.

Senior Manager/AD, Quality Assurance

Position Summary

The Senior Manager/AD of Quality Assurance role is critical to ensuring compliance with global GMP regulations and maintaining a robust Quality Management System (QMS) to support manufacturing operations. This role partners closely with CMC, Supply Chain, and Regulatory Affairs to ensure product quality, regulatory readiness, and continuous improvement across the organization. Reporting to the Sr. Director, Quality Assurance, the Quality Assurance role ensures collaboration across Elion program areas to drive timely delivery of all GMP documentation.

Key Responsibilities

GMP Quality & Manufacturing Support

• Provide quality oversight and support for GMP manufacturing operations from starting material to finished goods across contracted manufacturing and testing organizations.
• Partner with CMC to ensure compliance during routine operations, and ensure timely closure of records such as Deviations, CAPAs, Change controls etc.
• Ensure timely batch record review, product disposition and adherence to cGMP requirements.
• Review and approve GMP documentation such as batch records, SOPs, protocols, reports, and validation documentation.
• Support technology transfer, scale-up, and process validation activities.
• Partner with Supply Chain to ensure readiness for manufacturing and product distribution activities.

Quality Management System (QMS)

• Lead and continuously improve Quality Management Systems, including: Deviations, CAPAs, Change Control; Document Control; Risk Management; and Training Systems
• Ensure QMS aligns with FDA, EMA, ICH, and other global regulatory requirements.
• Drive continuous improvement initiatives to enhance compliance, efficiency, and inspection readiness.

Audits & Inspections

• Lead and support internal audits, supplier audits, and external regulatory inspections (FDA, EMA, other health authorities).
• Ensure timely and effective responses to audit observations and regulatory findings.
• Maintain inspection readiness across manufacturing and quality operations.

Leadership & Cross-Functional Collaboration

• Act as a strategic Quality partner to cross-functional teams.
• Communicate quality risks, trends, and performance metrics to senior leadership.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related scientific discipline (advanced degree preferred).
• 6-10 years of GMP Quality experience within the biotech or pharmaceutical industry.
• Experience supporting both clinical and commercial manufacturing, including GMP manufacturing operations.
• Strong hands-on experience with Quality Management Systems.
• Proven experience leading and supporting audits and regulatory inspections with deep knowledge of FDA, EMA, ICH, and global GMP regulations.
• Proficiency across systems and platforms (EDC, IRT, CTMs, eTMF, MS office suite) and ability to adapt to new IT applications on various devices.
• Inspection readiness mindset with an ability to drive continuous improvement and a risk-management approach
• Strong analytical and critical thinking skills to evaluate complex issues and ability to develop strategies and drive decision making to support study execution
• Outstanding communication skills, including the ability to understand and present technical information effectively.
• Effective time management, collaboration, organizational and interpersonal skills, conflict management, and problem-solving skills.
• Travel up to 20%
• Boston-based, strongly preferred