jadebiosciences
Associate Director, Quality Control
At a Glance
- Location
- Boston Chicago San Francisco Seattle
- Experience
- 10+ years
- Compensation
- r candidates for this role is $170,000 - $190,000. The final salary offered wil
- Posted
- 2026-02-17T10:35:11-05:00
Key Requirements
Domain Knowledge
- Biotech
- Pharmaceutical
- Regulatory
Requirements
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
Responsibilities
The Associate Director, Quality Control will lead critical Quality Control functions to support Jade’s product pipeline across various stages of development. The Associate Director will manage analytical method life cycle including method development, qualification, transfer and validation as phase appropriate. This individual will work very closely with internal stakeholders and external CDMO partners and will be responsible for developing and executing product release testing, stability study and product shelf-life management strategy whileensuring full quality compliance with regulatory requirements and internal quality systems.
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