Manager, R&D Quality

Hikma Pharmaceuticals USA Inc.•Columbus, OH

2d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

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.

Benefits

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave