Jade Biosciences · 8 hours ago
Associate Director/Director, Quality Control
United States
Full-time
Remote
Lead/Staff, Director/Executive
$170K/yr - $190K/yr
8+ years expJade Biosciences is focused on developing innovative therapies for autoimmune diseases. The Associate Director, Quality Control will lead Quality Control functions to support the product pipeline and manage analytical method life cycle while ensuring compliance with regulatory requirements.
BiotechnologyHealthcareHealth CareTherapeutics
Responsibilities
Work with both internal (Manufacturing, Quality Assurance, Regulatory and other key stakeholders) and external CDMO partners to develop and implement QC strategies appropriate for different phases of development programs
Oversee analytical method development, qualification, transfer and validation activities at and cross CDMOs
Develop product specifications and oversee product in-process, release, and stability testing strategy and execution in compliance with both cGMP and ICH guidance and internal quality standard
Work with Quality Assurance to create and manage QC documentation including SOPs, protocols, and technical reports
Collaborate cross-functionally with Manufacturing, QA, Regulatory, and R&D to support tech transfers and lifecycle management, regulatory filing and interactions etc
Manage CDMO relationships to ensure compliance with quality standards, timely deliverables, and effective communication
Review and approve CDMO generated data, investigations, and documentation
Ensure timely investigation and resolution of OOS results, deviations, and CAPAs
Serve as QC subject matter expert during regulatory inspections and audits
Qualification
Required
Master's or advanced degree in Chemistry, Biology, Biochemistry, or related field with 10+ years of related experience (7+ years of experience with PhD)
8+ years of experience in Quality Control management within the biotech or pharmaceutical industry
A strong quality compliance and collaborative mindset, and ability to thrive in a fast-paced working environment
Strong knowledge of cGMP, FDA, EMA, and ICH regulations
Strong experience in analytical method life cycle management including phase appropriate method qualification, transfer and validations from early to late phase development including BLA filing
Experience with common analytical techniques such as HPLC/UPLC, CE-SDS, ELISA, and cell-based assays for biologics development
Proven leadership in managing internal QC operations or external CDMOs
Excellent communication, organizational, and problem-solving skills
Company
Jade Biosciences
Jade Biosciences is developing transformative therapies to redefine the standard of care for inflammation and immunology indications.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$575MKey Investors
Fairmount Funds Management,Venrock
2025-12-16Post Ipo Equity· $45M
2025-10-07Post Ipo Equity· $135M
2025-04-29Post Ipo Equity· $300M
Leadership Team
Tom Frohlich
Chief Executive Officer
Brad Dahms
Chief Financial Officer
Recent News
2025-12-16
2025-12-15
Company data provided by crunchbase