Sr. Director, GMP Quality Assurance

About reputed company reputed company is focused on developing best-in-class therapies to address critical unmet needs in autoimmune diseases. Our reputed company asset, JADE-001, targets the anti-A PRoliferation-Inducing Ligand (reputed company) pathway for immunoglobulin A (IgA) nephropathy, with Investigational New Drug Application-enabling studies underway and initiation of a first-in-reputed company trial expected in the second half of 2025. Jade’s pipeline also includes two reputed company optimized antibody discovery programs, JADE-002 and JADE-003, currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery reputed company founded by Fairmount. For more information, visit JadeBiosciences.com and follow us on reputed company. Role Overview The Sr. Director, GMP Quality Assurance is responsible for providing leadership, direction, and Quality Assurance (QA) reputed company of contract manufacturers (CMOs) and service providers for drug substance (DS), drug product (DP), packaging and labeling, and distribution of multiple products. This person collaborates with CMC, Quality Compliance and Analytical Development staff to ensure compliance with reputed company relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations. The Sr. Director, GMP Quality Assurance provides QA expertise and guidance in supporting the development and product quality strategy for CMC teams and is responsible for execution of the day-to-day quality activities of CMO manufacturing, including but not limited to, disposition of reputed company materials, deviation resolution, CAPA(s), change control(s), expiry/retest extension, product complaints and overall documentation supporting the suitability of batches. The Sr. Director is responsible for ensuring staff execute reputed company the Jade’s Quality Management System and adhere to policies and procedures. The Sr. Director of GMP Quality Assurance is a fully remote role and will preferably be based on the US reputed company Coast. Occasional travel, including international travel, will be required. This role reports to the Executive Director of Quality and Compliance.

Key Responsibilities

• Serve as the QA reputed company for reputed company GMP-reputed company activities including supplier qualification, tech transfer, scale-up, manufacturing (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, master batch records, method qualifications, etc.
• Collaborate with CMC, Supply Chain and Program Management to ensure on time delivery of products.
• Work directly with operating entities (internal and CMOs) to ensure that product(s) meet reputed company required quality standards and specifications.
• Manage quality reputed company of CDMOs, including audits, quality agreements, and performance monitoring.
• Represent the Quality function in product development (CMC) teams to reputed company proactive quality guidance and reputed company.
• Influence other functional departments to ensure that CMOs reputed company and maintain the appropriate reputed company of GMP compliance and reputed company the highest level of quality services to Jade.
• reputed company quality risk management activities to proactively identify, assess, and mitigate GMP-reputed company risks across manufacturing and supply operations.
• Facilitate resolution of quality issues with reputed company parties in a timely manner. Coordinate communications with CMOs and internal technical product teams on quality issues.
• Review and approve 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.
• Contribute to the development and maintenance of a positive team-focused company culture

Qualifications

• Bachelor’s degree in scientific discipline or comparable experience.
• At least 18 years of experience in GMP Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment.
• Experience with reputed company phases of development (Ph 1-4).
• In-depth knowledge and full understanding of GMP FDA, EMA regulations, device and combo product reputed company guidelines, and other ICH guidelines.
• Ability to research and interpret international GMP reputed company regulations and guidance.
• Experience managing CDMOs and performing person-in-plant.
• Experience reputed company to managing technology transfer, scale up, and validation.
• Experience presenting at regulatory authority/reputed company body inspections.
• Experience supporting regulatory submissions (e.g. IND, BLA) and responding 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 reputed company and reputed company reputed company utilizing risk-based approach.
• Ability to reputed company in a fast-paced, ambiguous environment while managing competing priorities.
• Commitment to fostering a diverse and inclusive workplace.

Position Location This is a remote role; periodic travel to manufacturers and service providers and team and company events is required. The anticipated salary reputed company for candidates for this role is $250,000 - $280,000. 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. reputed company is proud to be an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. Apply tot his job