QA Manager & QP

at  eTheRNA

etherna provides research and manufacturing excellence by teaming up with highly skilled scientists, researchers and technical experts who are recognized for their contributions to the industry. We acquired substantial intellectual property and know-how over the years that support our exceptional leadership in mRNA and LNP innovation. With a careful balance in our skillset, state-of-the-art facilities and specialized equipment we tackle complex challenges and assure efficiency in our operations.
www.etherna.be | www.ethernamanufacturing.com

GENERAL JOB DESCRIPTION

The QA Manager – QP assures quality products and processes by establishing and enforcing quality standards and systems. The QA Manager - QP assures the continuous improvement and maintenance of the Global Quality Management System (QMS) within and for all departments of the company and ensures that all operations comply with international cGMP regulations and guidelines in general and Belgian laws and regulations in particular, as well as the company’s internal standards and assures the correct detection, reporting and closure of quality events, changes and other types of quality system related events and the timely release of the manufactured batches. The QP will be responsible for evaluation of execution and reporting of production and QC activities for the manufacture of API/IMP mRNA batches in compliance with eTheRNA procedures, IMPDs and EU GMP.
He/she reports into the Manufacturing Director and works in close collaboration with QA, QC and production departments.

EDUCATION

• Master’s degree in Pharmaceutical Sciences
• License to fulfill Qualified Person services in Belgium

EXPERIENCE

• Minimum of 7 years of relevant experience in pharma/biotech industry in a similar function.
• Registered Qualified Person in Belgium

OTHER QUALIFICATIONS, SKILLS AND ABILITIES

• Qualifications: Proactive, detail-oriented, excellent problem-solving skills, strong management and organizational abilities, exceptional interpersonal skills, knowledge of manufacturing methods, proficiency in process improvement, and detailed documentation practices
• Abilities: Collaborative, result-focused, well-organized, and adaptable. Strong initiative, fluency in English, and expertise in MS Office tools (Excel, Word, PowerPoint, Outlook)

The QA Manager - QP duties shall include, but not be limited to: