Procella Therapeutics AB is a start-up biopharmaceutical company on a mission to create stem cell-based therapy for heart disease and is seeking an outstanding Senior QA-Manager to join the growing QA team. If you are interested in this unique opportunity, please submit your application (including a cover letter).

About The Position

We are seeking a highly motivated individual to join us as QC Manager. The QC manager will be part of the development of Procella’s GMP Biochemistry laboratory and support to drive the development and implementation of it. At Procella you will be part of a great team with high competence, and you will be working at a patient-focused, growing and developing company that makes a difference.

As a QC Manager, you will be part of development of a QC GMP Biochemistry laboratory, setting resources, ensuring instrument and equipment qualifications, development of SOPs, methods and validation/verification of them while ensuring compliance at the outsourced CLOs. This role will work closely with cross functional teams internally (development, manufacturing, CMC and, regulatory). Reporting to the Head of Quality, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

Responsibilities

• Support in developing Procella’s GMP Biochemistry laboratory
• Handle various documentation revisions (including SOPs etc.)
• Develop/approve among other SOPs, methods, specification, validation/qualification documentation, reports
• Set strategy for method validation/verification and ensure implementation
• Set strategy for starting material testing
• Responsible for purchasing instruments, qualification and maintenance and calibration
• Support in validation (IQ/OQ/PQ) activities
• QC member in various cross-functionally projects such as tech transfers
• Act as an expert and be an advisor regarding quality control issues/queries

• Be responsible for GMP compliance within your area and provide oversight of outsourced activities
• Responsible for communication with clients in analysis issues.
• Perform method improvement work and trouble-shooting in collaboration with Clients
• Responsible for developing and setting up new methods for analysis of (release, IPC and raw materials) as needed
• Participate/support in audits and inspections

Qualifications

• You must have experience of management of GMP QC laboratory
• You have documented knowledge of in process controls such as automated cell counting, cell viability measurements, media biomarker analysis, or image-based culture analysis tools
• You are familiar with the analysis techniques; among other, flow cytometry and qPCR.
• Be able to speak / write Swedish and English fluently
• You have an understanding in biological manufacturing and testing (R&D and clinical manufacturing)
• A high-level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
• You have at least 10 years of experience from the quality control within pharmaceutical industry
• Extensive GMP knowledge and experience

Personal attributes

You are independent, good at driving your own work forward and you have a good ability to take your own initiatives. You are a natural QC leader who thrives in a role where communication and collaboration are in focus. You can create and maintain rewarding working relationships both externally and internally. Furthermore, with you handle new situations with ease as well as many different issues at the same time.

Equal Opportunity Work

At Procella we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.