Senior QA Leader, Quality Operations & Compliance

Keenova Therapeutics plc; Cranbury Township (NJ); On-site; USD 151,000 - 241,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Keenova Therapeutics plc is seeking a Senior Manager, Quality Assurance to oversee Quality Operations and Quality Systems at Cranbury, NJ and Rye, NY facilities. You will ensure cGMP compliance, manage batch release, and lead regulatory inspections while guiding quality initiatives across sites.

You will oversee deviations, CAPA, change control, and training programs, collaborating with Manufacturing, Regulatory Affairs and Supply Chain. Strong leadership and communication are essential.

Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline is required; advanced degree preferred.
• Minimum 8+ years of progressive experience in Quality Assurance, Compliance, and Quality Systems.
• Biologics/biotech/pharma experience required; 3–5 years people leadership experience.

Responsibilities

• Lead Quality Operations including manufacturing floor quality support, line clearance, sampling, material disposition and batch release.
• Develop and maintain Quality Assurance procedures, policies, processes to support compliant operations and continuous improvement.
• Manage Quality Systems, deviations, CAPA, change control, risk management, training, audits and inspection readiness.
• Lead regulatory inspections, customer audits, and internal audits; ensure inspection readiness.
• Oversee Product Quality Reviews and regulatory filing preparations; develop quality metrics for management reviews.

Skills

Leadership

Cross-functional collaboration

Quality mindset

Regulatory awareness

Analytical thinking

Project management

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Tools

QMS

CAPA

Change control

Job description

Keenova Therapeutics plc is seeking a Senior Manager, Quality Assurance to oversee Quality Operations and Quality Systems at Cranbury, NJ and Rye, NY facilities. You will ensure cGMP compliance, manage batch release, and lead regulatory inspections while guiding quality initiatives across sites.

You will oversee deviations, CAPA, change control, and training programs, collaborating with Manufacturing, Regulatory Affairs and Supply Chain. Strong leadership and communication are essential.