R&D Quality Manager — Lead QMS & Regulatory Compliance

Hikma Pharmaceuticals; Columbus (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. seeks an experienced Manager, R&D Quality to lead QA activities within the Analytical Research Department. You will oversee QMS, ensure cGMP compliance, and bridge R&D with operations and regulatory bodies.

Responsibilities include training, audits, documentation, and collaboration with Formulation Development, Analytical Research, Regulatory Affairs, and Manufacturing. A strong quality mindset and regulatory expertise are essential for success.

Qualifications

• Bachelor’s degree in a scientific field with 8–10 years in a lab/R&D or QA role.
• Proficient with Word, Excel, PowerPoint; strong written and verbal English.
• Expert knowledge of 21 CFR, ICH, ISO, cGMP, USP, FDA, EP, EMEA.

Responsibilities

• Lead R&D Quality activities during development and pre-approval.
• Build and maintain the Analytical Research QMS, training plans, LMS.
• Ensure compliance with cGMP and regulatory requirements.
• Support technology transfer and change control in development.
• Lead audits and QA documentation, mentor new staff.

Skills

Quality Assurance

GxP compliance

Regulatory knowledge

Documentation

Microsoft Office

English proficiency

Team collaboration

Change management

Education

Bachelor's degree in a scientific discipline

Master’s degree (preferred)

Job description

Hikma Pharmaceuticals USA Inc. seeks an experienced Manager, R&D Quality to lead QA activities within the Analytical Research Department. You will oversee QMS, ensure cGMP compliance, and bridge R&D with operations and regulatory bodies.

Responsibilities include training, audits, documentation, and collaboration with Formulation Development, Analytical Research, Regulatory Affairs, and Manufacturing. A strong quality mindset and regulatory expertise are essential for success.