Director, Quality Systems

Advancing medicine to save lives. Together. 

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.  

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.  

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. 

Duties And Responsibilities

• Develops and deploys the quality systems (e.g., management review, investigation, CAPA, change control including design control and process control) that ensures product manufacture and testing conform to defined requirements
• As system administrator for the site, works to correct errors/issues with the quality system, improve workflows and update document types and templates as needed
• Prepares monthly and quarterly reports to management showing trending of quality systems (prepares QMR reports and leads QMR meetings)
• Periodically reviews the suitability and effectiveness of the quality system with executive management
• Manages interactions with regulators concerning the quality of systems and processes
• Identifies and manages continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability, and cost improvements

Qualifications

• Bachelor’s Degree in STEM
• 15+ years’ experience in Quality, Manufacturing, or related field in the pharmaceutical products industry
• 5+ years management experience
• In depth knowledge of the regulatory environment for manufacture of biological products
• Strong leadership skills and demonstrated success in managing a team
• Strong analytical and problem-solving skills

Working Conditions

• Office environment

Physical Requirements

• PPE as required