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 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 culture
- Other duties, as assigned
Qualifications
- Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience in scientific discipline or comparable experience
- 10+ years of experience in GMP Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment
- 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 (e.g., FDA, EMA)
- Strategic thinker with a hands-on approach; comfortable balancing long-term planning with day-to-day execution
- Proven experience developing strong partnerships with cross functional key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork
- Must have excellent verbal, written, interpersonal and organizational skills
- Strong communication and influencing skills, as well as problem solving ability to evaluate quality matters and make decisions utilizing risk-based approach
- Must be self-motivated with the ability to thrive in a fast-paced, ambiguous environment while managing competing priorities
- Excellent computer skills with working knowledge of MS Office such as Word and Excel, Visio and Adobe Acrobat professional, and familiarity with SharePoint
- Commitment to fostering a diverse and inclusive workplace
Position Location
This is a remote role; up to 15% travel to team and company events is required.
The anticipated salary range for candidates for 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.
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