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.
