Kymera Therapeutics
Director, GCP Clinical Quality Assurance
Kymera Therapeutics, Watertown, Massachusetts, us, 02472
Who we are:Kymera is a clinical-stage biotechnology company pioneering the field of targeting 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 delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer. Founded in 2016, Kymera has been recognized as one of Boston's top places to work for the past several years. For more information about our science, pipeline, and people, please visit www.kymeratx.com.
How you'll contribute:
Providing quality oversight and compliance support to all non-clinical and clinical development programs including the development of strategic clinical quality oversight plans.
Serve as a member of clinical study teams, providing GLP/GCP/GVP 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) protocol deviation review and trending.
Assist and advise in the development of CAPA plans in response to Quality Events/audits/inspections and follow-up on CAPAs.
Assist with developing and executing the R&D 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 audits.
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 (e.g. DSUR, IB, IND).
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.
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 10+ 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 highly 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.
Extensive knowledge and understanding of all related study monitoring activities.
Comprehensive understanding of the infrastructure and operational characteristics of CROs and centralized services.
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%.
Kymera Therapeutics is proud to be an equal opportunity employer:Kymera is 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.
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How you'll contribute:
Providing quality oversight and compliance support to all non-clinical and clinical development programs including the development of strategic clinical quality oversight plans.
Serve as a member of clinical study teams, providing GLP/GCP/GVP 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) protocol deviation review and trending.
Assist and advise in the development of CAPA plans in response to Quality Events/audits/inspections and follow-up on CAPAs.
Assist with developing and executing the R&D 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 audits.
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 (e.g. DSUR, IB, IND).
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.
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 10+ 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 highly 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.
Extensive knowledge and understanding of all related study monitoring activities.
Comprehensive understanding of the infrastructure and operational characteristics of CROs and centralized services.
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%.
Kymera Therapeutics is proud to be an equal opportunity employer:Kymera is 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.
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