Senior Director, GCP/GLP Quality Assurance

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. 

 

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 contribute:

• Lead development and execution of the Clinical Quality strategy while ensuring that it aligns with Kymera’s business strategy, GCP/GLP/GVP standards, and FDA/EMA/ICH requirements  
• Develop, implement and monitor phase appropriate GCP/GLP/GVP Quality programs, policies and procedures to ensure compliance with applicable regulations  
• Develop, implement and execute a risk-based audit strategy for clinical and non-clinical studies 
• Lead and manage GLP/GCP/GVP audits program including oversight of consultant mediated and/or self-conducted Vendor, System, Study, and Process audit
• Providing quality oversight and compliance support to all GLP non-clinical and clinical development programs including the development of strategic clinical quality oversight plans 
• Serve as a member of clinical study teams, providing compliance guidance, to achieve continuous quality improvement and effective quality assurance
• Implement tolerance limits, metrics and key performance indicators to drive quality compliance and continuous improvement
• Provide day-to-day quality and compliance support, including issue management (triage/investigation/actions)
• Assist and advise in the development of CAPA plans in response to Quality events / audits / inspections and follow-up on CAPAs
• Participate in the evaluation and selection of CROs and other GLP/GCP/GVP service providers and establish Quality Agreements, as required
• Provide training sessions and mentor teams on topics related to GLP/GCP/GVP quality and related global regulations
• Review key non-clinical, safety and clinical documents including protocols/amendments, reports, study plans and regulatory documents
• Maintain an inspection awareness culture leading to a successful Inspection Readiness Program
• Establish Quality management governance and escalation structure and periodically report the state of R&D Quality and compliance to management at the Quality Management Review  

 

 

Skills and experience you’ll bring:

• Bachelor’s degree in life sciences, nursing, or related field. Advanced degree (MS or MBA) preferred 
• A minimum of 15+ years of experience in the biopharmaceutical/pharmaceutical industry
• Working knowledge of relevant FDA,