Manager, R&D Quality

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

Job Title

Manager, R&D Quality

Location

Columbus, OH

Job Type

Full time

Req ID

12413

Description

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Manager, R&D Quality to join our team.

In this role, you will be responsible for driving the management, oversight, and maintenance of the Quality Management System (QMS) specifically within our Analytical Research Department. You will serve as a vital bridge between scientific innovation and operational execution. This role collaborates daily with Research & Development teams (Formulation Development, Analytical Research, Regulatory Affairs) and plant operations (Manufacturing/Production, Procurement, Quality).

Under the direction of the Associate Director, R&D Quality, you will ensure all analytical processes, procedures, and documentation strictly align with current Good Manufacturing Practices (cGMP), internal Hikma corporate policies, and divisional guidelines. Additionally, you will guarantee total compliance with external regulatory authorities, including the FDA and DEA.

Key Responsibilities

• Responsibility for R&D Quality activities during the development and pre-approval phase of the products and their lifecycle
• Development and establishment of Quality Management System in Analytical Research including preparation of training plan and status, matrix and LMS Curricula)
• Monitor compliance, quality assurance and regulatory requirements and evaluate their impact on defined processes for R&D.
• Identify continuous improvement initiatives in quality and compliance related processes in R&D.
• Scientific and structural support to the R&D team on the following:
  • Preparation/review/approve of different product related documentation (external and internal)
  • Preparation/review/approve of different risk assessments
  • Support activities of technology transfer (R&D to manufacturing)
  • Change control/deviation/OOS/CAPA support during exhibit batch production and submission phase
  • Supporting to deficiency letters received by Authorities
• Assure high-quality QA documentation
• Participate in various audits including internal corporate audits and external customer or regulatory audits
• Perform internal audits of R&D laboratories
• Supplier assessment/vendor evaluation in development phase
• Participate in due diligences of potential external collaborators
• Participation in GMP equipment qualifications
• Reporting of QA results to the division heads
• Mentoring of new employees in R&D Quality
• Stay updated with regulatory and quality standards, evolutions in GxP compliance and best practices where needed, for supporting audit preparation at site.
• Adhere to the Company policies e.g. purchasing, travel, EHS, IT, Data Privacy Policy and all other policies in the Company
• Act according to the Hikma behavioral standards at any point in time, such as the Code of Conduct.

Qualifications

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Bachelor's degree in a scientific discipline with 8 to 10 years of combined experience in a laboratory environment, including R&D (Formulation Development and/or Analytical Research) or Quality Control, along with demonstrated Quality Assurance experience.
• Proficient in Microsoft Office applications, including Word, Excel, and PowerPoint.
• Strong verbal and written communication skills; intermediate-level English proficiency required.
• Expert knowledge of 21 CFR, ICH, ISO, cGMP, USP, FDA regulations, EP, and EMEA regulations.
• Teamwork and collaboration, with the ability to foster a team-oriented environment.
• Change management and innovation.
• Problem-solving and decision-making.
• Effective communication and ability to influence others.
• Initiative, accountability, and a results-driven mindset.

Preferred Qualifications

• Master's Degree in Pharmacy, Chemistry/Chemical engineering or Biochemistry plus 6 - 8 years experience in R&D and Quality in pharmaceutical industry specifically.

Equal Opportunity Employer

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.