Director, Quality Control

Role Summary

Director, Quality Control will lead critical Quality Control activities to support Jade’s product pipeline across various stages of development. The Director will manage analytical method life cycle including method development, qualification, testing, 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 strategy while ensuring full quality compliance with regulatory requirements and internal quality systems.

Responsibilities

• Work with both internal (other CMC functions, 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 batch release and stability testing, 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 other CMC functions, QA and Regulatory 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

Qualifications

• MS or PhD degree in Chemistry, Biology, Biochemistry, or related field with 10+ years of related experience
• 7+ years in Quality Control management for director level 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 development including phase appropriate method qualification, transfer and validations from early to late phase development including BLA filing
• Experience with common analytical techniques such as common compendial methods, 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

Skills

• Quality systems management
• Analytical method development and validation
• Regulatory compliance and inspections
• CDMO management and technology transfers
• Documentation and SOP development

Education

• MS or PhD in Chemistry, Biology, Biochemistry, or related field

Additional Requirements

• Position is fully remote with up to 15% travel domestically and/or internationally