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Full-Time

Director – Clinical Quality Assurance

Confirmed live in the last 24 hours

Korro Bio

Korro Bio

51-200 employees

Develops RNA-based therapies for diseases

Hardware
Biotechnology

Senior, Expert

Cambridge, MA, USA

Category
QA & Testing
Quality Assurance
Required Skills
Management
Google Cloud Platform
Requirements
  • 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
  • Able to travel domestically and internationally.
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.
  • 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

Korro Bio develops RNA-based therapies aimed at treating serious diseases that lack effective treatments. The company uses RNA editing to make precise modifications at the RNA level, which allows for accurate changes in protein function. This method is seen as more precise and potentially safer than traditional gene editing techniques. Korro Bio focuses on research and development to create new therapies, which it can market independently or through partnerships with larger pharmaceutical companies. The company serves healthcare providers, hospitals, and patients, and collaborates with academic institutions to enhance its research. Korro Bio's goal is to advance RNA editing technology to provide new treatment options for patients suffering from debilitating diseases.

Company Stage

IPO

Total Funding

$451.5M

Headquarters

Cambridge, Massachusetts

Founded

2019

Growth & Insights
Headcount

6 month growth

0%

1 year growth

2%

2 year growth

25%
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Simplify's Take

What believers are saying

  • The $70 million raised for clinical trials and growth positions Korro Bio to advance its pipeline and achieve significant milestones.
  • The appointment of industry veterans like Dr. Rachel Meyers and Tim Pearson to the board strengthens the company's leadership and strategic direction.
  • Korro Bio's stock price surge of 171% in November indicates strong market confidence and potential for high returns.

What critics are saying

  • The biopharmaceutical market is highly competitive, and Korro Bio must continuously innovate to maintain its edge.
  • The success of RNA editing therapies is still uncertain and hinges on successful clinical trials and regulatory approvals.

What makes Korro Bio unique

  • Korro Bio's focus on RNA editing allows for precise single base modifications, offering a potentially safer and more accurate alternative to traditional gene editing and gene therapy.
  • The company's strategy of leveraging machine learning to enhance RNA delivery and platform development sets it apart from competitors.
  • Korro Bio's recent $70 million private placement and merger with Frequency Therapeutics provide substantial financial backing and expanded capabilities.