Associate Director, GMP Quality Drug Product

Position Overview 

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. 

Key Responsibilities 

• 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 enhance quality system effectiveness, operational efficiency, compliance maturity, and inspection readiness, including the use of digital and AI-enabled quality tools where appropriate. 

• Manage contractors/consults for daily operations and ensure alignment with company goals, timelines and compliance initiatives. 

Qualifications 

Required 

• M.S. or B.S. in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Engineering, or a related scientific discipline; equivalent experience considered. 

• 10+ years of experience in pharmaceutical or biotechnology Quality Assurance, with significant experience supporting drug product manufacturing, quality systems, and GMP operations. 

• Demonstrated expertise in GMP regulations, quality systems management, supplier qualification, auditing, deviation management, CAPA programs, and validation oversight. 

• Strong experience overseeing contract manufacturing organizations and global external manufacturing networks. Proven ability to detect, communicate, assess, and process conformance issues. 

• Proven track record supporting regulatory inspections and successfully managing Quality Assurance activities for clinical and/or commercial products. 

• Thorough understanding of FDA, EMA, ICH, and global GMP regulatory requirements. 

• Strong leadership, communication, and cross-functional influence skills, with the ability to drive quality-focused decision-making across a matrix organization. 

• Entrepreneurial mindset and comfort operating in a fast-paced, growth-oriented environment. 

• Proficiency using AI and digital tools to improve efficiency, compliance oversight, investigation effectiveness, and overall quality performance. 

Preferred 

• Experience establishing and scaling quality systems within emerging biotechnology organizations. 

• Lead Auditor certification (ASQ CQA, ISO Lead Auditor, or equivalent) is a plus but not required. 

• Experience supporting commercial product launches and lifecycle quality management. 

• Experience with small-molecule pharmaceutical products and late-stage clinical development programs. 

• Experience managing global supplier qualifications and audit programs across multiple contract manufacturing and testing partners. 

Why Join Celea Therapeutics 

• Play a pivotal role in advancing life-changing therapies for patients with devastating lung diseases. 

• Shape the foundation of a Phase 3–ready biotech poised for significant growth. 

• Collaborate with a passionate, mission-driven leadership team. 

• Competitive compensation and equity package. 

Compensation 

Transparency is one of our values, and that includes how we pay. The anticipated salary range for this role is $200,000 - $217,000 plus bonus and equity. Where an offer lands within the range reflects the candidate’s experience, skills, and internal equity — and we welcome open conversations about compensation from the first call, so there are no surprises at the offer stage.