Manager, R&D Quality

About the role

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).

Responsibilities

• Development and establishment of Quality Management System in Analytical Research including preparation of training plan and status, matrix and LMS Curricula
• Maintain 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)
• 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
• Perform internal audits of R&D laboratories
• Supplier assessment/vendor evaluation in development phase
• Participation in due diligences of potential external collaborators
• 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

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.

Qualifications

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

Skills

• 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.

Benefits

We offer a competitive compensation package, comprehensive benefits, and a supportive work environment.

Pay

The salary range for this position is $75,000 - $95,000 annually.

Schedule

This is a full-time position with standard business hours.