Associate Director, Quality Assurance — GMP & CMC Leader

Protagonist Therapeutics; Newark (CA); On-site; USD 175,000 - 225,000; Full time

Benefits offered by this job

Health care benefits

401(k) Plan

Flexible Vacation Policy

Job summary

Protagonist Therapeutics is seeking an Associate Director, Quality Assurance to lead QA activities for GMP manufacturing and CMC programs. You will provide regulatory-focused QA leadership, review batch records, deviations, and CAPA, and guide cross-functional teams toward compliant product releases.

You will report to the Executive Director QA and contribute to risk-based QA strategies, ensuring inspections readiness and regulatory alignment across EU, FDA, and ICH guidelines.

Qualifications

• Bachelor's degree in a scientific or related discipline required.
• 10+ years in biotech/pharma with QA experience.
• Experience preparing for regulatory inspections and audits.
• Demonstrated ability to interpret EU, FDA and ICH regulations.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead QA activities for assigned CMC program(s) supporting GMP API manufacturing.
• Provide QA oversight of GMP manufacturing and analytical operations.
• Review/approve Master Batch Records and change controls for regulatory compliance.
• Review/approve product specifications to ensure scientific justification and quality.
• Oversee external laboratories and method lifecycle activities (qualification/validation).
• Review investigations (OOS/OOT/deviations) with robust CAPA and root-cause analysis.
• Partner with cross-functional teams to mitigate quality risks affecting patients.
• Ensure regulatory readiness and support inspections and internal audits.

Skills

Quality Assurance

Regulatory inspections

Cross-functional collaboration

Documentation

GMP compliance

Education

Bachelor's Degree in a scientific or related discipline

Advanced degree preferred

Job description

Protagonist Therapeutics is seeking an Associate Director, Quality Assurance to lead QA activities for GMP manufacturing and CMC programs. You will provide regulatory-focused QA leadership, review batch records, deviations, and CAPA, and guide cross-functional teams toward compliant product releases.

You will report to the Executive Director QA and contribute to risk-based QA strategies, ensuring inspections readiness and regulatory alignment across EU, FDA, and ICH guidelines.