Director, Quality Operations — GMP Leader & Regulatory Strategy

Keros Therapeutics; Lexington (MA); On-site; USD 185,000 - 229,000; Full time

Job summary

Keros Therapeutics is seeking a Director of Quality Operations to provide quality oversight across manufacturing for clinical and commercial products. You will interact with Clinical Operations, Regulatory Affairs, Supply Chain, and CMOs to ensure GMP compliance and robust QMS.

The role emphasizes real-time batch review, CAPAs, and regulatory readiness, with a focus on driving quality improvements and mentor-mentee development within the team.

Qualifications

• 12+ years CGMP quality experience in pharmaceutical/biopharmaceutical/biotechnology.
• 8+ years leading a Quality function.
• 3+ years at the Director level with direct reports.
• Strong knowledge of biological manufacturing processes and testing.

Responsibilities

• Provide quality oversight of all manufacturing operations for clinical development and commercial products.
• Develop and implement SOPs for the Quality Operations function.
• Own real time batch record review and deviation resolution.
• Quality oversight of Deviations, Change Controls, CAPAs, etc., including those at the CMO sites.
• Developing and implementing appropriate quality training for the team.
• Assuring availability of all required documentation and support for the Annual Product Reviews.
• Review of CMC sections for regulatory submissions and participation in control strategy development.
• Quality review and approval of Technology transfer protocols and final reports.
• Preparation for regulatory inspections at the CMO sites.
• Define, develop, and implement short-term and long-term strategies for Quality Operations and QMS.
• Review and recommend corrective actions to ensure consistency with Quality Operations.
• Use CAPA activities to drive quality improvements and issue resolution.
• Represent Quality Operations in audits, inspections, and client assessments.
• Assist in GMP audits for vendors and remediation actions.

Skills

CGMP quality experience

Leadership

Project management

Communication skills

Regulatory understanding

Vendor management

Travel readiness

Education

Bachelor’s Degree in Biological sciences or Engineering

Advanced degree

Job description

Keros Therapeutics is seeking a Director of Quality Operations to provide quality oversight across manufacturing for clinical and commercial products. You will interact with Clinical Operations, Regulatory Affairs, Supply Chain, and CMOs to ensure GMP compliance and robust QMS.

The role emphasizes real-time batch review, CAPAs, and regulatory readiness, with a focus on driving quality improvements and mentor-mentee development within the team.