Director – Clinical Quality Assurance

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
• Builds the company’s quality system
• Interprets regulations, determines quality requirements, and works 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
• Partners with all line functions to ensure GxP compliance for all clinical development programs by providing guidance and serving as an expert in the interpretation 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.