Orro
Director, Clinical Quality Assurance
Orro, Cambridge, Massachusetts, us, 02140
Company Summary:
Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro’s lead program is Alpha-1 Antitrypsin Deficiency (AATD). Korro is based in Cambridge, Massachusetts.We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values -
Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity
form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.
Key Responsibilities:
The Director, Clinical Quality Assurance will oversee the management of GCP activities internally at Korro and externally with vendors and service providers, leading to process improvement and inspection readiness. The ideal candidate will have experience working across GxP activities in the biotech sector.Accountable for comprehensive quality management strategy to ensure compliance with regulatory requirements, including FDA and other relevant authorities.Develop, review, and revise Standard Operating Procedures (SOPs) to ensure alignment with regulatory standards and industry best practices.Build the company’s quality system.Interpret regulations, determine quality requirements, and work closely with internal cross-functional teams and external partners to execute quality strategy to support overall product quality.Lead Vendor, Site and Internal Audits and propose relevant sponsor process improvement tasks/initiatives.Partner with all line functions to ensure GxP compliance for all clinical development programs by providing guidance and serving as an expert in the interpretation of regulatory requirements and expectations.Work closely with clinical study teams to ensure appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans.Assess all GMP, GLP and GCP compliance risks to the clinical development programs and develop and implement risk mitigation measures.Establish key quality metrics and performance indicators to monitor the effectiveness of clinical quality assurance activities.Qualifications:
Bachelor’s or Master’s degree in a related scientific field with 6-8 years, respectively, of relevant experience in the biopharmaceutical/pharmaceutical industry.A minimum of 5 years of experience in a GCP related discipline.Strong working knowledge and interpretation of global GxP regulations in drug development from pre-clinical to post-marketing safety.Proficient in risk assessment and root cause analysis tools.Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results.Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.Meticulous attention to detail, with a focus on quality, accuracy, and compliance.Ability to work in a fast-paced, dynamic environment and adapt to changing priorities.Experience in RNA therapeutics and LNP-formulated drugs is highly desirable.Able to travel domestically and internationally.
Benefits:
Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.
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Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro’s lead program is Alpha-1 Antitrypsin Deficiency (AATD). Korro is based in Cambridge, Massachusetts.We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values -
Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity
form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.
Key Responsibilities:
The Director, Clinical Quality Assurance will oversee the management of GCP activities internally at Korro and externally with vendors and service providers, leading to process improvement and inspection readiness. The ideal candidate will have experience working across GxP activities in the biotech sector.Accountable for comprehensive quality management strategy to ensure compliance with regulatory requirements, including FDA and other relevant authorities.Develop, review, and revise Standard Operating Procedures (SOPs) to ensure alignment with regulatory standards and industry best practices.Build the company’s quality system.Interpret regulations, determine quality requirements, and work closely with internal cross-functional teams and external partners to execute quality strategy to support overall product quality.Lead Vendor, Site and Internal Audits and propose relevant sponsor process improvement tasks/initiatives.Partner with all line functions to ensure GxP compliance for all clinical development programs by providing guidance and serving as an expert in the interpretation of regulatory requirements and expectations.Work closely with clinical study teams to ensure appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans.Assess all GMP, GLP and GCP compliance risks to the clinical development programs and develop and implement risk mitigation measures.Establish key quality metrics and performance indicators to monitor the effectiveness of clinical quality assurance activities.Qualifications:
Bachelor’s or Master’s degree in a related scientific field with 6-8 years, respectively, of relevant experience in the biopharmaceutical/pharmaceutical industry.A minimum of 5 years of experience in a GCP related discipline.Strong working knowledge and interpretation of global GxP regulations in drug development from pre-clinical to post-marketing safety.Proficient in risk assessment and root cause analysis tools.Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results.Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.Meticulous attention to detail, with a focus on quality, accuracy, and compliance.Ability to work in a fast-paced, dynamic environment and adapt to changing priorities.Experience in RNA therapeutics and LNP-formulated drugs is highly desirable.Able to travel domestically and internationally.
Benefits:
Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.
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