GCP QA

Job description

Here´s a chance to join our dynamic team at Ribocure Pharmaceuticals AB as a GCP QA. Where you will contribute in Ribocures mission 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.

At Ribocure the spirit is positive and you feel the community amongst co-workers and consideration of each other. In this fast pace environment, everyone is committed to delivering well all the while finding time to have fun and share culture exchanges cross countries as well.

As a GCP QA, you will play a critical role in ensuring the quality and compliance of our clinical development. 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. Preferably you are based in the Gothenburg area. If you are not, it is a requirement to visit the site continuously.

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. We will do the selection continuously so please apply at www.randstad.se. If you have questions, please contact Karolina Andersson at karolina.andersson@randstad.se

For Ribocure and Randstad, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity. 

Responsibilities

You will join a competent and inspiring team and your main responsibilities will be:

• Ensure appropriate development, maintenance and continuous improvement of the Quality Management System (QMS)
• Support inspection readiness activities and 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
• 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

Qualifications

To thrive and be happy in the role, we see that you bring the following experience and skill-sets:

• University degree, preferably in medical or biological science or discipline associated with clinical research
• Minimum of 5 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).

It will be seen as a merit if you also are certified in audit training and if you can demonstrate experience and ability to drive process improvement and/or functional work.

As a co-worker you are engaged, analytical, pragmatic and solution oriented. You like collaboration and build relationships in the organization with ease. You also have good communication skills and you are humble and flexible in relation to others.

About the company

Ribocure Pharmaceuticals AB

Ribocure Pharmaceuticals AB is a clinical stage biotech company with a business focus on the development of cutting-edge RNA therapeutics. Ribocure’s primary focus lies in addressing the significant medical gaps in rare diseases involved in the fields of cardiovascular, renal, and oncology. The company is dedicated to the discovery and development of groundbreaking drug assets utilizing advanced oligonucleotide technologies.
Operating as a subsidiary of Ribo Life Science Co., Ltd., Ribocure leverages the advantages of a vertically integrated oligonucleotide research platform and excels in translational and clinical operations. Our comprehensive technological platforms encompass the entire process, from sequence design, screening, and optimization to delivery technologies and large-scale commercial CMC capacity.