Jade Biosciences
Biotechnology
Director,GMPQualityAssurance
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“Director, GMP Quality Assurance at Jade Biosciences. Skills: GMP Quality Assurance, CDMO management, Regulatory compliance. Provide QA support across product pipeline. Serve as key partner to CMC and cross-functional”
Industry & Context.
Problem solving ability; Risk-based approach
Occasional domestic and international travel, Up to 15% travel
What They're Looking For.
Must Have
Bachelor's degree and 15 years of experience or Master's degree with 12+ years of experience, 10+ years of experience in GMP Quality Assurance, Experience with all phases of development (Ph 1-4 including commercial), In-depth knowledge and full understanding of GMP FDA, EMA regulations, device and combo product related guidelines, and other ICH guidelines, Ability to research and interpret international GMP related regulations and guidance, Experience managing CDMOs, Experience related to managing technology transfer, scale up, and validation, Experience supporting regulatory authority/notified body inspections, Experience supporting regulatory submissions (e.g. IND, BLA) and responses to health authority queries, Excellent computer skills with working knowledge of MS Office such as Word and Excel, Visio and Adobe Acrobat professional, and familiarity with SharePoint
Nice to Have
Experience with Python and machine learning frameworks, Experience with Kubernetes
What You'll Do.
Provide QA support across product pipeline
Serve as key partner to CMC and cross-functional
guidance and risk-based input
Support development and product quality strategies
Provide QA oversight of contract manufacturers
Ensure alignment with GMP requirements and Jade quality
Coordinate day-to-day GMP quality activities for outsourced manufacturing
Track and archive quality records
compliant documentation and batch release decisions
Promote cross-program alignment
consistency in QA practices
Serve as QA lead for assigned GMP-related activities
Provide quality oversight of CDMOs
Manage manufacturing (cell bank
Manage disposition of clinical materials
Review and approve quality records
Approve change controls
Approve temperature excursions
Approve product complaints
Approve expiry/retest
Approve stability protocols/reports
Approve master batch records
Approve method qualifications
Ensure on-time delivery of products
Ensure compliance with relevant cGMP regulations
Support archival of documents/records
Maintain QA related tracking logs
Ensure product(s) meet all required quality standards
Support management of Quality Agreements
Coordinate project management
Coordinate cross-functional review
Coordinate approval workflows
Represent Quality function in product development (CMC) teams
Provide proactive quality guidance
Provide quality decisions
Influence other functional departments
Ensure CMOs achieve and maintain GMP compliance
Lead quality risk management activities
Identify GMP-related risks
Assess GMP-related risks
Mitigate GMP-related risks
Facilitate resolution of quality issues
Coordinate communications with CMOs
Coordinate communications with internal technical product teams
Review CMC sections of regulatory filings
Embed quality across development and manufacturing activities
Participate in regulatory authority inspections
Support regulatory authority inspections
Support internal audits
Support development/maintenance of Quality SOPs
Contribute to development of positive team-focused company culture
How You'll Work.
Team & Collaboration
CMC teams; Cross-functional teams; Product development teams; Internal stakeholders; External stakeholders; Operating entities; Regulatory teams; Clinical Supply Chain teams; Program Leadership teams
Communication Scope
Verbal communication; Written communication; Interpersonal skills; Organizational skills; Influencing skills
Process & Methodology
Project coordination, Program alignment
Full Job Description
About Jade Biosciences 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, JADE101, 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 JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, 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. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn. Role Overview 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 bas
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