Director, CMC QA

Korro Bio, Inc.

Director, CMC QA overseeing quality for Korro Bio's vendors ensuring compliance with cGMP standards. Collaborating with internal teams and managing quality systems to support global clinical programs.

Posted 6/2/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesLead💰 $200,000 - $240,000 per yearWebsite

About the role

Key responsibilities & impact

Ensure that manufacturing operations at Contract Manufacturing Organizations (CMOs) and partners comply with regulatory requirements and internal Korro Bio quality standards
Lead clinical lot disposition and batch record review, ensuring products are released in compliance with Korro Bio's procedures and applicable regional requirements
Oversee GMP Quality Systems activities at external partners, including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations ensuring timely and compliant execution and closure
Plan, oversee, conduct, and document qualification and periodic cGMP audits of raw material vendors, CMOs, contract testing laboratories, contract packagers/labelers, and logistics providers/distributors
Provide quality and technical input to cross-functional project teams, and review internal and external documentation including protocols, reports, test methods, specifications, master batch records, and SOPs
Partner with CMC, Supply Chain, and Regulatory Affairs to assess overall product quality performance, identify product-specific quality and compliance risks, and develop risk-based mitigation plans
Lead and manage the GMP Vendor Oversight Program, ensuring vendor performance is monitored and risk mitigation plans are implemented and executed as required
Develop quality metrics, assess results in collaboration with CMC, drive corrective actions with vendor quality units, and report findings to management
Lead quality initiatives including regulatory inspection preparations and ongoing inspection readiness activities
Develop, implement, and/or enhance quality systems to ensure continued compliance with company procedures and regulatory requirements
Support the review of CMC sections of regulatory submissions, including INDs and IMPDs, and contribute to responses to health authority questions related to manufacturing and quality

Requirements

What you’ll need

Bachelor's degree in Chemistry, Biology, or Life Sciences required
Minimum of 10 years of cGMP-related experience in the biopharmaceutical or pharmaceutical industry, including 8+ years of direct QA experience in a cGMP environment
Demonstrated knowledge of Quality Systems and cGMP within an FDA-regulated environment
Demonstrated knowledge of Good Distribution Practices
Auditing experience is required
Demonstrated experience providing quality oversight of CMOs, including audits, batch review, and issue resolution
Analytically strong with practical knowledge of how to identify key performance metrics and quality indicators to set targets and identify areas for improvement

Benefits

Comp & perks

Korro offers competitive compensation, including equity-based compensation
Comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance
Dependent care flexible spending account
Company-funded health savings account
Free parking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

cGMPQuality Systemsauditingbatch record reviewCAPAschange controlsOOS investigationsrisk-based mitigationquality metricsregulatory submissions

Soft Skills

leadershipanalytical skillscross-functional collaborationproblem-solvingcommunication

Certifications

Bachelor's degree in ChemistryBachelor's degree in BiologyBachelor's degree in Life Sciences