Director, GMP Quality Assurance

Jade Biosciences•Boston, MA

1d•$210,000 - $235,000•Remote

About The Position

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. 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.

Requirements

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

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