Associate Director, GMP Quality Drug Product

About Celea Therapeutics

Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for "sky," our name reflects our mission to rise above the status quo and deliver therapies that change lives. Our lead program, deupirfenidone (LYT-100), is currently in Phase 3 clinical development with active candidate enrollment, representing a potential new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.

Rising above the status quo takes a team as strong as its science, and we hire and work by five values:
accountability — owning outcomes and acting like owners;
transparency — talking straight and building trust;
collaboration — achieving together what no one could alone;
innovation — challenging accepted ideas and taking smart risks; and passion — bringing energy and heart to the mission.

As we prepare for our next stage of growth and clinical advancement, Celea is seeking an experienced, strategic, and hands‑on Associate Director, GMP Quality Drug Product to serve as the end‑to‑end quality owner for drug product manufacturing and related quality systems across the product lifecycle. Reporting to the Senior Director of Quality, this role will provide comprehensive quality oversight of drug product manufacturing operations, contract development and manufacturing organizations (CDMOs), and associated GxP activities to ensure compliance, product quality, and uninterrupted supply.

In the near term, the focus will be ensuring successful qualification, audit readiness, manufacturing oversight, and quality execution as deupirfenidone (LYT-100) advances through late‑stage development. Over time, this individual will strengthen quality systems, support global regulatory inspections and submissions, drive continuous compliance improvements, and help establish the quality foundation necessary for commercialization. This role will be instrumental in guiding Celea through its next chapter of clinical and commercial growth.

This position is based in Boston, Hybrid with 3 days onsite.

• Serve as the Quality Assurance lead and primary quality representative for all assigned drug product manufacturing activities.

• Provide quality oversight for internal and external drug product manufacturing, packaging, and labeling operations, ensuring compliance with GMPs, regulatory commitments, and company quality standards.

• Lead qualification and ongoing oversight of drug product CDMOs, laboratories, suppliers, and service providers, including conducting and managing risk‑based audits and ensuring timely closure of audit observations.

• Review and approve GMP documentation, including batch records, deviations, investigations, CAPAs, change controls, validation protocols and reports, product quality reviews, and quality agreements.

• Oversee nonconformance, deviation, and investigation programs, ensuring robust root cause analysis, effective corrective and preventive actions, and timely issue resolution.

• Partner closely with Manufacturing, Technical Operations, Regulatory Affairs, Supply Chain, and Quality Control to support manufacturing campaigns, technology transfers, process validation activities, and commercial readiness initiatives.

• Monitor manufacturing and quality performance metrics, identify compliance risks and trends, and implement proactive mitigation strategies to protect product quality and ensure supply continuity.

• Lead inspection readiness activities and provide support for regulatory authority inspections, customer audits, and due diligence assessments.

• Ensure appropriate oversight and disposition of drug product batches, working collaboratively with Qualified Persons and Manufacturing Quality teams as required.

• Provide quality leadership for quality risk management activities, including risk assessments associated with manufacturing processes, suppliers, facilities, deviations, and process changes.

• Support development and maintenance of quality systems in compliance with FDA, EMA, ICH, and global regulatory requirements.

• Drive continuous improvement initiatives that…