Director, GMP Quality Assurance

Director, GMP Quality Assurance

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade's lead candidate, JADE
101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade's pipeline also includes JADE
201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE
301, an undisclosed antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount.

The Director, GMP Quality Assurance (QA) provides QA support across Jade's product pipeline across various stages of development. This role serves as a key partner to CMC and cross-functional teams, offering QA expertise, guidance and risk-based input to support development and product quality strategies.

The role provides QA oversight of contract manufacturers (CMOs) and service providers supporting cell bank, drug substance (DS), drug product (DP), finished drug product (FDP) packaging and labeling, and product distribution, ensuring alignment with GMP requirements and Jade quality standards.

Additionally, the position coordinates day-to-day GMP quality activities for outsourced manufacturing, including the intake, routing, tracking, and timely archival of quality records such as batch disposition, deviations, CAPAs, change controls, expiry/retest extensions, and product complaints. The Director collaborates with internal and external stakeholders to support timely, compliant documentation and batch release decisions. Additionally, the role may also support other QA Leads to promote cross-program alignment, consistency in QA practices, and balanced workload distribution.

This is a fully remote role, preferably based on the U.S. West Coast, with occasional domestic and international travel. The position reports to the Senior Director, GMP Quality Assurance.

Key Responsibilities

• Serve as the QA lead for assigned GMP-related activities including quality oversight of CDMOs, tech transfer, scale-up, manufacturing (cell bank, DS, DP, FDP), and disposition of clinical materials
• Quality reviewer and approver for quality records such as change controls, CAPAs, deviations, temperature excursions, product complaints, expiry/retest, stability protocols/reports, master batch records, method qualifications, etc.
• Collaborate with CMC, Supply Chain, Analytical Development and Program Management to ensure on-time delivery of products and compliance with all relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations
• Supports archival of documents/records, quality metrics and develop/maintain QA related tracking logs
• Work directly with operating entities (internal and CMOs) to ensure that product(s) meet all required quality standards and specifications
• Supports management of Quality Agreements, including project coordination, cross-functional review, and approval workflows
• Represent the Quality function in product development (CMC) teams to provide proactive quality guidance and decisions
• Influence other functional departments to ensure that CMOs achieve and maintain the appropriate levels of GMP compliance and provide the highest level of quality services to Jade
• Lead quality risk management activities to proactively identify, assess, and mitigate GMP-related risks across manufacturing and supply operations
• Facilitate resolution of quality issues with internal and external parties in a timely manner
• Coordinate communications with CMOs and internal technical product teams on quality issues
• Review CMC sections of regulatory filings, as needed
• Collaborate cross-functionally with CMC, Regulatory, Clinical Supply Chain, and Program Leadership teams to ensure quality is embedded across development and manufacturing activities
• Participate in and support regulatory authority inspections and internal audits
• Supports development/maintenance of Quality SOPs
• Contribute to the development and maintenance of a positive team-focused company…