We are looking for a new colleague to SOBI's global Clinical & CMC Compliance team!
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,300 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobi's revenues amounted to SEK 14.2 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at Sobi.com
We are looking for a new colleague to our global Clinical & CMC Compliance team! The team currently consists of 4 people located in Switzerland and the Director Clinical & CMC Compliance in Stockholm. The team is part of the Global Quality department of Sobi, with the objective of implementing, developing, and maintaining standards and quality systems to make sure that the company is compliant with GxP requirements in relation to Clinical research, including IMP management and bioanalytical sample testing. The team also ensures quality oversight of Sobi's non-clinical development projects. The position as QP IMP will be a replacement for the current QP IMP. It is a global lead role, focused on IMP management for Sobi's worldwide clinical programs. It involves collaboration primarily with R&D/Clinical and Medical Affairs departments and QA Managers within GMP/GDP. It also involves interactions with the internal network of QPs and collaboration with external Contract Manufacturing Organisations (CMOs) as well as Sobi's partner organisations.
- Registered Qualified Person on Sobi's manufacturing authorisation for production of IMP for clinical trials.
- Perform release of DS, DP, bulk IMP as well as certification of packaged and labelled IMP for use in clinical trials.
- Ensure that production of clinical trial materials and related activities are conducted according to current GMP requirements, either directly or as part of oversight of CMOs.
- Ensure that batches have been manufactured and tested in accordance with the requirements of the IMPD.
- Assess and approve IMP related documentation, such as specifications, certificates of analyses, protocols and reports, batch documentation and deviations.
- Development of SOPs and Quality agreements
- Perform GMP audits of suppliers. Participate in audits and inspections by authorities and external parties.
- Meet required qualifications of a QP as specified in LVFS 2004:7
- Sc. degree in Pharmacy, Biochemistry, Chemistry or other relevant degrees.
- Fluent in Swedish and English verbally and in writing.
- Minimum 5 years of experience from the pharmaceutical industry, including experience with biologics.
- In depth Up-to-date knowledge and understanding of relevant regulations and quality standards
- Extensive experience from working in an international organization and across borders.
- High ethical standards, trustworthy, operating with integrity
- Strong collaborative, partnering, and interpersonal skills
- Strong communication skills
- Ability to work independently
- Ability to prioritize, take decisions and act upon them
You would be part of a committed and competent team where an understanding of both GMP and GCP guidelines and regulations are crucial. If you have prior experience as QP this is a unique opportunity for you to join us!
For more information regarding the role, please get in touch with responsible consultant Doruntina Hoxha,
We look forward to your application!