NextCell Pharma is a rapidly growing research driven company searching for a Head of Quality Assurance (QA) / Qualified Person (QP) to join the company. NextCell's drug candidate ProTrans represents a platform technology for developing and manufacturing cell therapies to treat autoimmune diseases and inflammatory conditions. The company has come the furthest with ProTrans for the treatment of type 1 diabetes where both safety and efficacy in the preservation of patients' ability to produce their own insulin have been demonstrated in clinical drug trials. The company has been relying on contract manufacturing organizations for production of ProTrans and a strategic decision was taken early last year to start our own production. We recently finished the construction of a brand new GMP-facility.
The position is full-time with placement in Stockholm. We evaluate applications on an ongoing basis and welcome your application today!About the position
As Head of QA and QP at NextCell Pharma, you would be a key person in the organization. You will act as a line manager for a small team and have the overall responsibility of and develop the Quality Assurance and Quality Control organization and activities. As line manager you will hire, train, develop and lead staff as well as prioritize their work.
As a QP, you will be named on NextCell Pharma’s manufacturing license for IMP and responsible for Certification of IMP. You will be responsible for the Competent Authority contacts within the area of responsibility.
You will ensure NextCell Pharma has in place a suitable Quality Management System capable of fulfilling the regulatory and business needs.
In the role you will also support the organization with strategic advice in Quality Assurance.
You will report to CEO, be a member of NextCell Pharma’s Management Team and responsible to ensure and represent the Quality Assurance / Quality Control Unit as well as liaise with key departments to ensure strategic objectives are met.Your profile
Key qualifications for the position include:
• University degree in Science/Engineering is required, preferably MSc in Pharmacy or similar
• Multiple years of professional experience in QA/QC and 2-5 years’ experience working as Qualified Person
• Experience as line manager
• Meets the requirement in LVFS 2004:7 and have experience from biologic manufacturing processes and cell biology
• Experience from ATMP production is preferred
• Experience from cell and tissue biology, biotechnological techniques, cell processing, characterization and potency testing is an advantage
• Experience from auditing
• Very good understanding of GMP, regulatory requirements in EU as well as US and RoW
• Excellent language skills in Swedish and English
As person you are result oriented, have the possibility to prioritize and have adequate interpersonal skills. You must feel comfortable working with deadlines in a changing environment and see it as a challenge to solve issues in a pragmatic and proactive way. We offer a role with challenging and varied tasks, management responsibility, competent authority contacts, customer contacts and with great opportunities to actively participate in the company’s continued development.About the organisation
About NextCell Pharma AB
NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 8,5% in FamicordTX, a CAR-T start-up in oncology and 100 % of Cellaviva, Scandinavia's largest stem cell bank for family saving stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).
NextCell has an existing tissue establishment, biobank and GDP permission. Our cleanroom facility neighbors Karolinska University Hospital in Huddinge.