QA Specialist

Our mission is to build a world-leading RNA therapeutics R&D company in Sweden and help patients all over the world. We are dedicated to developing innovative treatments that make a difference in patients' lives. At Ribocure, we foster a culture of excellence and are committed to the highest standards of quality in everything we do.

As a QA Specialist, you will play a critical role in ensuring the quality and compliance of our clinical development, with a primary focus on GCPQA. You will work closely with cross-functional teams, including Clinical Operations, Regulatory Affairs and our own Ribocure Clinic, to uphold the highest standards of quality. You will also collaborate with the QA department within Suzhou Ribo (Parent company of Ribocure).

Your responsibilities will include conducting audits, managing CAPAs, and maintaining compliance with regulatory requirements across various GxP areas, with a particular emphasis on GCP, all crucial for supporting Ribocure’s mission and strategic goals.

You will report to the Head of Clinical Operations and QA but will have a dotted line directly to Ribocure's CEO for any escalation needs, ensuring the independence of the QA function. The career level will be adjusted based on the candidate's experience, allowing for flexibility in responsibilities and expectations.

Main responsibilities:

• Ensure appropriate development, maintenance and continuous improvement of the Quality Management System (QMS)
• Support inspection readiness activities
• Prepare and host inspections from regulatory authorities
• Develop the annual audit program in collaboration with the Heads of Clin Ops and Ribocure Clinic
• Conduct internal and external audits to assess compliance with GCP (Good Clinical Practice) and other applicable GxP regulatory requirements, aligned with annual audit program.
• Collaborate with cross-functional teams to ensure quality is maintained throughout the product lifecycle.
• Support Ribocure Clinic staff to ensure quality and compliance at our Ribocure Clinic.
• Review and approve quality-related documentation, including policies/SOPs and related documentation, vendor evaluation, validation protocols etc.
• Manage deviations, CAPAs (Corrective and Preventive Actions), and change controls to ensure timely and effective resolution.
• Monitor and report on key quality metrics, driving continuous improvement initiatives.
• Collaborate with Suzhou Ribo QA department to ensure appropriate alignment, support in quality issues/CAPA assessments, knowledge sharing, joint training sessions etc.
• Provide training and support to staff on GCP and current regulations, quality assurance procedures and best practices.
• Stay current with industry trends and regulatory changes to ensure the company's compliance and competitive edge.

Essential Requirements:

• University degree, preferably in medical or biological science or discipline associated with clinical research
• Minimum of 3 years experience in quality assurance within the pharmaceutical or biotech industry
• Proven audit experience, including conducting GCP audits and preparing audit reports.
• Strong knowledge of regulatory requirements and industry standards (e.g., FDA, EMA, ICH).
• Analytical and problem-solving skill.
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Proficiency in using (electronic) quality management systems and software

Desirable Requirements:

• Certified audit training
• Demonstrated ability to drive process improvement and/or functional work

Join Ribocure and contribute to our mission of delivering high-quality treatments that improve patients’ lives. If you are passionate about quality and have the expertise we are looking for, we encourage you to apply. Please submit your CV and cover letter by latest 15th of August. Note that candidates will be assessed on a continuous basis.

We offer a competitive salary, comprehensive benefits package, and opportunities for growth and advancement. We are an equal opportunity employer and welcome applicants from all backgrounds. We also offer you opportunities to grow with our fast-expanding global organization towards being one of the leading players in oligonucleotide therapeutics.

Hiring manager: Rebeckha Magnusson, Head of Clinical Operations & QA