Senior Director, GCP Quality Assurance

Kymera Therapeutics • Watertown, MA

1d • $235,000 - $330,000

About The Position

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:
Lead the development and execution of the Clinical Quality strategy in alignment with Kymera’s business objectives and applicable GCP/GLP/GVP and FDA/EMA/ICH requirements.
Design, implement, and maintain phase-appropriate Clinical Quality programs, policies, procedures, and governance to ensure regulatory compliance.
Develop and execute a risk-based audit strategy and oversee the GLP/GCP/GVP audit program, including vendor, system, study, and process audits conducted internally or via consultants.
Provide quality oversight and compliance support across non-clinical, clinical, and safety programs, including development of strategic quality oversight plans and participation on study teams.
Deliver day-to-day quality support, including issue triage, investigation, CAPA development and follow-up, and continuous quality improvement initiatives.
Establish and monitor quality metrics, tolerance limits, and key performance indicators to drive compliance and performance.
Support CRO and vendor selection and oversight, including establishment of Quality Agreements.
Review key non-clinical, safety, and clinical documentation (e.g., protocols, amendments, study plans, reports, and regulatory submissions).
Build and sustain inspection readiness through training, inspection preparedness activities, and an inspection-aware culture.
Provide GLP/GCP/GVP training and mentorship to cross-functional teams.
Report on R&D Quality and compliance status to management through Quality Management Review and established escalation pathways.

Requirements

• Bachelor’s degree in life sciences, nursing, or related field
• A minimum of 15+ years of experience in the biopharmaceutical/pharmaceutical industry
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations
• Experience with First in Human trial management
• Extensive knowledge and understanding of ICH E6 GCP Guideline, FDA and EU Requirements
• Experience and understanding of Data Integrity requirements and electronic systems used in Clinical trials
• Direct experience in managing Health Authority GCP Inspections. Experience supporting BIMO inspections is preferred
• Proven experience with developing strong partnerships with cross functional key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamwork
• Strong problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
• Ability to drive results on time and take ownership and accountability for shared information
• Strong communication and influencing skills, as well as problem solving ability to evaluate quality matters and make decisions utilizing risk-based approach
• Experience with authoring and reviewing clinical regulatory filings
• Ability to travel up to 15%

Responsibilities

• Lead the development and execution of the Clinical Quality strategy in alignment with Kymera’s business objectives and applicable GCP/GLP/GVP and FDA/EMA/ICH requirements.
• Design, implement, and maintain phase-appropriate Clinical Quality programs, policies, procedures, and governance to ensure regulatory compliance.
• Develop and execute a risk-based audit strategy and oversee the GLP/GCP/GVP audit program, including vendor, system, study, and process audits conducted internally or via consultants.
• Provide quality oversight and compliance support across non-clinical, clinical, and safety programs, including development of strategic quality oversight plans and participation on study teams.
• Deliver day-to-day quality support, including issue triage, investigation, CAPA development and follow-up, and continuous quality improvement initiatives.
• Establish and monitor quality metrics, tolerance limits, and key performance indicators to drive compliance and performance.
• Support CRO and vendor selection and oversight, including establishment of Quality Agreements.
• Review key non-clinical, safety, and clinical documentation (e.g., protocols, amendments, study plans, reports, and regulatory submissions).
• Build and sustain inspection readiness through training, inspection preparedness activities, and an inspection-aware culture.
• Provide GLP/GCP/GVP training and mentorship to cross-functional teams.
• Report on R&D Quality and compliance status to management through Quality Management Review and established escalation pathways.

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 $235,000 – $330,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees