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Associate Director/Director, Quality Assurance
1 month ago
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:
- Accountable for comprehensive quality management strategy to ensure compliance with regulatory requirements, including FDA and other relevant authorities.
- 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.
- Develops and implements standards, policies, and procedures for GMP, GLP and GCP compliance, doing so in a way that engenders support and full participation of stakeholders.
- 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.
- Builds the company's quality system
- Participates in the evaluation and selection of contract manufacturing sites, analytical testing sites, clinical storage, and distribution depots, CROs and other service providers used to support the clinical development programs.
- Oversees and manages vendors supporting quality and compliance.
- Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
- Oversees the QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports and essential clinical study documents.
- Assess all GMP, GLP and GCP compliance risks to the clinical development programs and develop and implement risk mitigation measures.
- 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 knowledge of cGMP, FDA, and CHMP/EU regulations
- Proficient in risk assessment and root cause analysis tools.
- Experience in setting up a QMS
- Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers
- 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.
