Associate Director, GCP Quality

Kymera Therapeutics • Watertown, MA

17h • $160,000 - $240,000

About The Position

The Associate Director, GCP Quality is responsible for developing, implementing, and maintaining the Good Clinical Practice (GCP) Quality framework to support Kymera’s global clinical development programs. This role provides independent quality oversight of clinical trials, CROs, and vendors, ensuring compliance with ICH GCP, global regulatory requirements, and internal quality standards.
The individual will play a key role in operational study team GCP support, audit management, risk-based quality management, continuous improvement initiatives and inspection readiness, as the organization advances toward late-stage development and commercialization.

Requirements

• Bachelor’s degree in life sciences or related field required.
• 8+ years of experience in GCP Quality, Clinical QA, or Clinical Operations with strong QA focus in a sponsor organization
• Deep knowledge of ICH GCP (E6 R2/R3), with strong understanding of sponsor oversight obligations
• Experience with risk-based monitoring and RBQM frameworks, TMF systems and electronic platforms
• Working knowledge of global regulatory requirements and strong understanding of data integrity principles.
• Strong communication and influencing skills and ability to work cross-functionally in a fast-paced biotech environment
• Strong problem solving and operational execution skills

Nice To Haves

• Advanced degree (MS, PharmD, PhD) preferred.
• Experience supporting regulatory inspections is a plus

Responsibilities

• Provide GCP quality oversight of Kymera’s global clinical trials to ensure compliance with ICH E6 (R2/R3), FDA, EMA, and applicable regional regulations
• Provide Quality oversight and investigation support for vendor and internal Quality Issues and CAPA management
• Support risk-based quality management system (RBQM) through assessment, characterization and escalation of quality risks
• Lead qualification and ongoing oversight of CROs and clinical vendors, via review of vendor quality documentation and audit responses
• Ensure appropriate quality agreements are in place and monitor vendor performance metrics and risk indicators
• Execute on Kymera’s GCP audit strategy for investigator sites and internal processes, through effective CAPA management
• Contribute to development and maintenance of GCP-related SOPs and policies in alignment with Kymera’s QMS
• Support a GCP training program across clinical development and promote a culture of quality

Benefits

• Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
• The anticipated base salary range for this role is $160,000 – $240,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director