Full-Time

Director – Clinical Quality Assurance

Posted on 8/28/2024

Korro Bio

Korro Bio

51-200 employees

Develops RNA-based therapies for diseases

Biotechnology
Healthcare

Senior, Expert

Cambridge, MA, USA

Onsite position at One Kendall Square, Building 1400, Cambridge, MA 02139.

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 currently 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 bring to 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 make significant scientific advancements in medicine accessible to patients in need.

Company Stage

IPO

Total Funding

$383.7M

Headquarters

Cambridge, Massachusetts

Founded

2019

Growth & Insights
Headcount

6 month growth

-1%

1 year growth

-2%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • Korro Bio raised $70M for clinical trials and growth in April 2024.
  • Partnership with Novo Nordisk targets cardiometabolic diseases like obesity and diabetes.
  • Recent FDA approval of RNA therapy may accelerate Korro Bio's regulatory pathway.

What critics are saying

  • Potential competition from Beam Therapeutics in RNA editing technologies.
  • Merger with Frequency Therapeutics may lead to integration challenges.
  • Stock price surge could lead to increased scrutiny and volatility.

What makes Korro Bio unique

  • Korro Bio uses RNA editing for precise protein function modifications.
  • Their platform targets diseases with limited or no current treatment options.
  • Korro Bio's RNA editing is considered superior to traditional gene editing.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) Retirement Plan

401(k) Company Match

Company Equity

INACTIVE