Job Title: Manager, R&D Quality
Location: Columbus, OH
Job Type: Full time
Req ID: 12413
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, three R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
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,…