Director of Quality Assurance

Trebla Talent; San Francisco (CA); On-site; USD 210,000 - 270,000; Full time

Job summary

Trebla Talent seeks a Director of GMP Quality to advance small molecule programs from clinical development toward commercialization. This leadership role oversees GMP quality across development programs and the external manufacturing network, collaborating with Technical Operations, Supply Chain, Regulatory Affairs, and other cross-functional teams.

You will lead audits, investigations, CAPA, and continuous improvement, ensuring compliance with global GMP regulations and guiding quality

Qualifications

• 10+ years of industry experience in GMP, Quality Assurance
• Demonstrated experience supporting GMP Quality across commercialization
• Deep knowledge of global GMP regulations and guidance
• Demonstrated experience with GMP audits, investigations, root cause analysis, and CAPA development and implementation.

Responsibilities

• Lead GMP Quality oversight across development programs and external manufacturing network.
• Partner with Technical Operations, Supply Chain, Regulatory Affairs, and other cross-functional stakeholders to drive quality readiness and alignment.

Skills

GMP Quality Assurance

GMP Audits

CAPA Development

Root Cause Analysis

Regulatory Knowledge

Cross-functional Collaboration

Job description

Position

Director, Quality Assurance (GMP)

Reports To

Vice President, Regulatory Affairs

Compensation

$210,000-270,000

Role Summary

Seeking a Director of GMP Quality to play a key role in advancing small molecule programs from clinical development toward commercialization. This person will lead GMP Quality oversight across development programs and external manufacturing network, partnering closely with Technical Operations, Supply Chain, Regulatory Affairs, and other cross-functional stakeholders.

Requirements

• 10+ years of industry experience in GMP, Quality Assurance
• Demonstrated experience supporting GMP Quality across commercialization
• Deep knowledge of global GMP regulations and guidance
• Demonstrated experience with GMP audits, investigations, root cause analysis, and CAPA development and implementation.