Director, Product Quality Lead

Position Title: Director, Product Quality Lead

Department: Quality

Reports To: VP, CMC Quality

Location:  Princeton, NJ (Preferred) or South San Francisco, CA - On site 4 days a week (Mon to Thurs)

Job Overview

Kardigan is seeking a Director, Product Quality Lead (PQL) to provide end-to-end Quality leadership for designated products as the company advances toward becoming a global, multi-product commercial-stage biopharmaceutical company. The PQL is accountable for ensuring that the right product quality strategy, risk posture, and execution plan are in place in a compliant, phase-appropriate manner. 

This role spans the product lifecycle from pre-clinical and first-in-human development through pivotal clinical trials, commercial filing and approval. Scope includes critical raw materials (where applicable), intermediates, drug substance, drug product, process validation, technology transfer, and external manufacturing quality oversight. 

The successful PQL combines deep CMC development experience, strong Quality judgment, and practical business orientation. They guide CMC program teams by articulating the impact of trade-offs and residual risks, and making timely risk-based decisions that balance science, compliance, quality, innovation, and patient need. 

Essential Duties and Responsibilities

CMC Program Leadership 

• Develop and drive the end-to-end product quality strategy for assigned products, ensuring alignment with program objectives, regulatory expectations, and long-term commercialization goals.
• Serve as the Quality representative on CMC program teams, ensuring quality expectations and deliverables are clearly defined and achieved across technical functions. 
• Provide Quality oversight of development and manufacturing activities, ensuring phase-appropriate application of GMP and regulatory requirements. 
• Partner cross-functionally to ensure product quality considerations are effectively integrated throughout the product lifecycle. 
• Orchestrate the development of an end-to-end control strategy, partnering closely with SMEs from Drug Substance and Drug Product Development. 
• Lead product-specific risk assessments and guide teams in evaluating quality risks, trade-offs, and long-term implications of key decisions. 
• Promote pragmatic, risk-based approaches that maintain compliance while enabling efficient product development. 
• Oversee execution of key Quality processes, including change controls, deviations, investigations, and complaints as applicable. 
• Provide Quality leadership for technology transfer, process validation, stability program development, and other lifecycle activities. 

CDMO Quality Partnerships, Regulatory Filing Support and Inspection Readiness 

• Provide Quality oversight of CDMOs through established governance mechanisms, including Quality Agreements, quality review forums, issue escalation, and continuous improvement activities. 
• Build effective partnerships with CDMOs while maintaining independent Quality judgment and accountability. 
• Act as the Quality lead for CMC regulatory filings and agency responses. 
• Lead inspection readiness activities, ensuring that both internal CMC stakeholders and CDMOs are prepared to successfully manage pre-approval inspections from global health authorities 
• Support interactions with global health authorities. 

Qualifications and Preferred Skills

• Bachelor’s degree in life sciences (e.g. organic chemistry, chemical engineering, or a related technical discipline) required; advanced degree preferred. 
• 12+ years of relevant CMC (e.g. Quality, Product Development, Analytical Development, Regulatory) experience. 
• Strong knowledge of small molecule development required; direct technical experience in process development and combination product strongly preferred. 
• Successful track record leading Quality-related CMC activities from research or early clinical development through registration-enabling development, filing, and approval. 
• Strong understanding of ICH, FDA, EMA, GMP, and global quality expectations governing product/process development, manufacturing, testing, stability, and lifecycle management. 
• Hands-on experience authoring, reviewing, and supporting Module 3 / CMC regulatory submissions and CMC-related regulatory responses, including IND, IMPD, NDA, MAA, and comparable filings 
• Demonstrated ability to review scientific and technical documents, evaluate scientific data, and translate findings into quality decisions and clear recommendations. 
• Strong project leadership, communication, and stakeholder-management skills in a fast-paced, matrixed, team-oriented environment.