Associate Director, GCP Quality

Описание вакансии

Who we are:

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.

How we work:

• PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
• COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
• BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you’ll make an impact:

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.

• 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

Skills and experience you’ll bring:

• Bachelor’s degree in life sciences or related field required. Advanced degree (MS, PharmD, PhD) preferred.
• 8+ years of experience in GCP Quality, Clinical QA, or Clinical Operations with strong QA focus in a sponsor organization
• Experience supporting regulatory inspections is a plus
• 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

Equal Employment Opportunity

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Compensation

• 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.
• Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.