R&D Quality Manager - Analytical Research & Compliance

RXinsider LTD.; Columbus (OH); On-site; USD 110,000 - 160,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks a Manager, R&D Quality to drive the Quality Management System within Analytical Research, collaborating with Formulation Development, Analytical Research, Regulatory Affairs, and Manufacturing teams.

You will ensure all analytical processes align with cGMP, company policies, and regulatory expectations, including FDA and DEA compliance. Strong leadership and QMS expertise are essential.

Qualifications

• Bachelor's degree in a scientific discipline with 8–10 years in a laboratory/R&D or QA environment.
• Proficient in Word, Excel, and PowerPoint.
• Strong verbal and written communication skills; intermediate-level English.
• Expert knowledge of 21 CFR, ICH, ISO, cGMP, USP, FDA regulations, EP, and EMEA regulations.

Responsibilities

• R&D Quality activities during development and pre-approval phases of products and lifecycle.
• Develop and implement Quality Management System in Analytical Research, including training plan and LMS curricula.
• Monitor compliance and regulatory requirements and assess impact on R&D processes.
• Identify continuous improvement opportunities in quality and compliance in R&D.
• Provide scientific/structural support for documentation, risk assessments, tech transfer, and change control activities.
• Ensure high-quality QA documentation and participate in internal/external audits.
• Perform internal audits of R&D laboratories and supplier evaluations in development stage.
• Mentor new employees in R&D Quality and stay updated on regulatory standards.

Skills

Strong communication

Microsoft Office

English proficiency

Teamwork

Problem-solving

Decision-making

Change management

Accountability

Results-driven

Education

Bachelor's degree in a scientific discipline

Master's Degree in Pharmacy/ Chemistry/ Chemical engineering or Biochemistry

Tools

Microsoft Office Suite

Job description

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks a Manager, R&D Quality to drive the Quality Management System within Analytical Research, collaborating with Formulation Development, Analytical Research, Regulatory Affairs, and Manufacturing teams.

You will ensure all analytical processes align with cGMP, company policies, and regulatory expectations, including FDA and DEA compliance. Strong leadership and QMS expertise are essential.