Director, GMP Quality Assurance

🕒 vor 1 Monat

🏄 California, Illinois, +3 weitere Bundesländer – Remote

🏄 California – Remote 🌽 Illinois – Remote 🗽 New York – Remote 🍂 Massachusetts – Remote ☕ Washington – Remote

💵 $210.000 - $235.000 / Jahr

⏰ Vollzeit

🔴 Experte

🔧 QA-Ingenieur (Qualitätssicherung)

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Jade Biosciences

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2024

🏥 Gesundheitswesen

🏭 Fertigung

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jade Biosciences ist ein Biotechnologieunternehmen im klinischen Stadium, das potenziell erstklassige Therapien entwickelt, die darauf abzielen, den Behandlungsstandard für Autoimmunerkrankungen zu revolutionieren. Sein führender Kandidat, JADE101, ist ein Antikörper, der darauf ausgelegt ist, das Zytokin APRIL (A PRoliferation-Inducing Ligand) zu hemmen und wird zur Behandlung der IgA-Nephropathie (IgAN) entwickelt. Das Unternehmen baut seine Pipeline aus Projekten in der Entdeckungsphase auf, die von Paragon Therapeutics lizenziert sind, und konzentriert sich darauf, klinische Programme voranzutreiben, um neue Behandlungen für Patienten mit Autoimmunerkrankungen bereitzustellen.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

• Up to 15% travel to team and company events