Senior Director, Clinical QA & Audit Strategy

Korro Bio, Inc.; Cambridge (MA); Vor Ort; USD 190.000 - 220.000; Vollzeit

Benefits dieser Stelle

Equity-based compensation

Medical benefits

401(k) retirement plan

Life insurance

Dependent care FSA

Free parking

Zusammenfassung

Korro Bio, Inc. is seeking an Associate Director, Clinical QA in Cambridge, MA to provide hands-on quality oversight for clinical and nonclinical programs, ensuring compliance with GCP, GLP, and GCLP.

The role includes audits of CROs, laboratories, and sites, plus leading quality initiatives across study teams. You will partner with Clinical Operations, Regulatory Affairs, and Data Management, traveling up to 20% domestically and internationally, to protect patient safety and data integrity

Qualifikationen

• Bachelor's degree in Life Sciences or related field required.
• Minimum of 10 years in biopharmaceuticals or clinical research with at least 7 years in GCP/Clinical QA.
• Strong experience overseeing outsourced clinical/nonclinical studies (CROs, labs, service providers).
• Experience auditing investigator sites and GCP vendors such as CROs and clinical laboratories.
• Experience auditing GLP nonclinical facilities and/or GCLP labs.
• Working knowledge of ICH E6, 21 CFR 11/50/54/56/58/312, EU Clinical Trials Regulation 536/2014, and GCLP principles.

Aufgaben

• Serve as the primary quality partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Data Management, and Nonclinical teams.
• Plan, conduct, report, and follow up on audits of GCP/GLP/GCLP providers and investigator sites.
• Communicate observations and drive corrective actions to closure.
• Manage quality events, deviations, investigations, CAPAs, and assess serious breaches.
• Support vendor selection, qualification, and Quality Agreements as needed.
• Review key study documents from a quality perspective (protocols, ICFs, plans, TMF).
• Lead or support inspection readiness activities and prepare responses to inspections.
• Develop and maintain quality systems, SOPs, work instructions, and training.
• Track audit findings and quality metrics; report to Quality leadership and teams.
• Support regulatory submissions and health authority interactions.

Kenntnisse

GCP

GLP

GCLP

Audit planning

Vendor audits

Investigator site audits

Quality oversight

Regulatory inspections

Ausbildung

Bachelor's degree in Life Sciences or related field

Tools

ICH E6 (R3)

21 CFR Part 11

EU CTR No. 536/2014

GCLP principles

Jobbeschreibung

Korro Bio, Inc. is seeking an Associate Director, Clinical QA in Cambridge, MA to provide hands-on quality oversight for clinical and nonclinical programs, ensuring compliance with GCP, GLP, and GCLP.

The role includes audits of CROs, laboratories, and sites, plus leading quality initiatives across study teams. You will partner with Clinical Operations, Regulatory Affairs, and Data Management, traveling up to 20% domestically and internationally, to protect patient safety and data integrity