Director, Good Manufacturing Processes, Quality Assurance

Scorpion Therapeutics; South San Francisco (CA); On-site; USD 210,000 - 275,000; Full time

Job summary

IDEAYA Biosciences is seeking a Director of GMP Quality Assurance to lead quality operations for drug products and biologics from toxicology through Phase 3. The role oversees QA for CMC, manufacturing, and IT systems while driving continuous improvement and regulatory readiness.

Responsibilities include leading QA support for clinical materials, vendor oversight, and support for regulatory submissions and inspections in a fast-paced, development-focused environment.

Qualifications

• BS in Life Sciences, Chemistry, Engineering, or related field.
• 12+ years biopharma QA experience, including 8+ years supporting development-stage programs.
• 5+ years in GxP environments supporting small molecules and biologics.
• Expertise in GMP compliance, regulatory requirements (FDA, EMA, ICH) and vendor management.
• Proven experience with clinical manufacturing, analytical validation, and regulatory audits.
• Preferred advanced degree (MS/PhD/PharmD).

Responsibilities

• Provide strategic and operational GMP compliance leadership across CMC, manufacturing, and IT systems.
• Lead QA support for clinical trial materials.
• Manage vendor and contract manufacturing oversight.
• Support regulatory submissions and inspections.
• Develop and maintain quality systems and SOPs.
• Drive continuous improvement initiatives.

Skills

GMP compliance

Regulatory audits

Vendor management

Cross-functional leadership

Clinical manufacturing

Education

BS in Life Sciences or related

8+ years development-stage QA experience

5+ years in GxP environments

Job description

Role

Director of GMP Quality Assurance at IDEAYA Biosciences, overseeing quality operations for drug products and biologics from toxicology through Phase 3.

Responsibilities

• provide strategic and operational GMP compliance leadership across CMC, manufacturing, and IT systems;
• lead QA support for clinical trial materials;
• manage vendor and contract manufacturing oversight;
• support regulatory submissions and inspections;
• develop and maintain quality systems and SOPs;
• and drive continuous improvement initiatives.

Requirements

• BS in Life Sciences, Chemistry, Engineering, or related;
• 12+ years of biopharma QA experience, including at least 8 years supporting development-stage programs;
• 5+ years in GxP environments supporting small molecules and biologics;
• expertise in GMP compliance, regulatory requirements (FDA, EMA, ICH), and vendor management;
• proven experience with clinical manufacturing, analytical validation, and regulatory audits.

Preferred

• advanced degree (MS, PhD, PharmD).

High-Value

• biologics and small molecules, development through Phase 3, GxP compliance, cross-functional collaboration with CMC, regulatory, clinical ops, and vendors, and experience hosting regulatory inspections.

WorkSetup

• onsite in South San Francisco, CA, four days/week, with travel up to 10% domestically and internationally.