Director, Quality Control

About Jade Biosciences 

Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. Our lead candidate, JADE101, is designed to inhibit the cytokine APRIL (A Proliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN), a chronic kidney disease that can impair kidney function over time. JADE101 aims to reduce harmful IgA antibodies, lower proteinuria (a key marker of kidney damage), and preserve long-term kidney function. A Phase 1 healthy-volunteer study of JADE101 is ongoing, with interim, biomarker-rich data expected in the first half of 2026. Jade’s pipeline also includes a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both currently in preclinical development. For more information, visit JadeBiosciences.com and follow us on LinkedIn. 

Role Overview 

The Director, Quality Control will lead critical Quality Control activities to support Jade’s product pipeline across various stages of development. The Director will manage analytical method life cycle including method development, qualification, testing, transfer and validation as phase appropriate. This individual will work very closely with internal stakeholders and external CDMO partners and will be responsible for developing and executing product release testing, stability study and product shelf-life strategy while ensuring full quality compliance with regulatory requirements and internal quality systems.

Key Responsibilities 

• Work with both internal (other CMC functions, Quality Assurance, Regulatory and other key stakeholders) and external CDMO partners to develop and implement QC strategies appropriate for different phases of development programs
• Oversee batch release and stability testing, method development, qualification, transfer and validation activities at and cross CDMOs
• Develop product specifications and oversee product in-process, release, and stability testing strategy and execution in compliance with both cGMP and ICH guidance and internal quality standard
• Work with Quality Assurance to create and manage QC documentation including SOPs, protocols, and technical reports
• Collaborate cross-functionally with other CMC functions, QA and Regulatory to support tech transfers and lifecycle management, regulatory filing and interactions etc.
• Manage CDMO relationships to ensure compliance with quality standards, timely deliverables, and effective communication
• Review and approve CDMO generated data, investigations, and documentation
• Ensure timely investigation and resolution of OOS results, deviations, and CAPAs
• Serve as QC subject matter expert during regulatory inspections and audits

Qualifications 

• MS or PhD degree in Chemistry, Biology, Biochemistry, or related field with 10 years of related experience
• 7 years in Quality Control management for director level within the biotech or pharmaceutical industry
• A strong quality compliance and collaborative mindset, and ability to thrive in a fast paced working environment
• Strong knowledge of cGMP, FDA, EMA, and ICH regulations
• Strong experience in analytical method development including phase appropriate method qualification, transfer and validations from early to late phase development including BLA filing
• Experience with common analytical techniques such as common compendial methods, HPLC/UPLC, CE-SDS, ELISA, and cell-based assays for biologics development
• Proven leadership in managing internal QC operations or external CDMOs 
• Excellent communication, organizational, and problem-solving skills

Position Location 

This is a fully remote role with up to 15% domestic and/or international travel.

The anticipated salary range for director level in this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster.

Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.