Senior QA & Compliance Leader - GMP Operations

Keenova Therapeutics plc; Northern (KY); Hybrid; USD 151,000 - 241,000; Full time

Job summary

Keenova Therapeutics plc seeks a Senior Manager of Quality Assurance to oversee Quality Operations and Quality Systems at its Cranbury, NJ and Rye, NY facilities. You will ensure cGMP compliance, lead batch release, material disposition, and line clearance, and drive inspection readiness.

The role requires 8+ years in QA, biotech/pharma experience, and strong leadership across cross-functional teams. This position is on-site with travel as needed, offering a competitive base and bonus potential.

Qualifications

• Minimum 8+ years in Quality Assurance, Compliance, and Quality Systems in pharma.
• Experience in Biologics/Biopharmaceuticals and biotech operations.
• Experience leading quality operations on manufacturing floors and packaging.
• Proven track record with regulatory inspections (FDA/foreign)
• Strong knowledge of cGMP, QSR, ICH guidelines and data integrity.
• Leadership experience with demonstrated ability to mentor teams.
• Excellent technical writing and documentation review skills.
• Ability to influence across Quality, Manufacturing, Regulatory, and Supply Chain.

Responsibilities

• Provide leadership for Quality Operations and Quality Systems at Cranbury, NJ and Rye, NY facilities.
• Oversee batch release, raw material review, in-process quality, and line clearance activities.
• Lead deviation investigations, CAPAs, and effectiveness monitoring.
• Support regulatory inspections and customer/audit readiness.
• Maintain Quality Management System and contract manufacturer quality agreements.
• Manage training programs and risk assessment activities.

Skills

Leadership

Quality Assurance

Regulatory compliance

Quality systems

CAPA investigations

Audit management

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Tools

Quality Management System (QMS)

Deviation management

Change control

Document control

Job description

Keenova Therapeutics plc seeks a Senior Manager of Quality Assurance to oversee Quality Operations and Quality Systems at its Cranbury, NJ and Rye, NY facilities. You will ensure cGMP compliance, lead batch release, material disposition, and line clearance, and drive inspection readiness.

The role requires 8+ years in QA, biotech/pharma experience, and strong leadership across cross-functional teams. This position is on-site with travel as needed, offering a competitive base and bonus potential.