Quality Manager in Cancer Research Company
- Zelluna Imunotherapy AS
- Quality Manager
Zelluna Immunotherapy is an exciting and dynamic early-stage biotech company based in Oslo and developing a new and unique class of cellular immunotherapies. The company is pioneering the development of T-Cell Receptor (TCR) guided Natural Killer cells (TCR-NK) as an allogeneic off-the-shelf cellular treatment option for solid cancer patients.
Our vision is to build a leading off-the-shelf cell therapy company and bring safe and effective new treatment options to cancer patients.
We are seeking a Quality Manager to support the development of our novel TCR-NK therapies and be responsible for Quality across the organization. The successful candidate will be passionate and excited by our approach and is someone who thrives in a continuous learning start-up culture as well as being dedicated to working with a team to deliver on our collective purpose.
· Building and maintaining a pragmatic and fit for purpose quality management system within
Zelluna’s research and development non-GxP environment
· Responsible for quality oversight of external vendors (CDMO, CRO, suppliers) involved in our product development
· Build and adhere to company documentation system and other regulatory requirements by assisting with planning, scheduling and carrying out both external and internal GxP audits and inspections
· Building an internal training system and ensuring that the development teams adhere to the principles, guidelines and best practices of the QA strategy as defined
· Provide expertise within the field of Quality Assurance for CMC
· Responsible for the quality evaluation, audits and continuous quality oversight of suppliers, including CDMO/CRO involved in GxP activities; oversee compliance (GMP and GCP) auditing program to fulfil regulatory requirements
· Oversee risk assessments to determine level of compliance risk. Lead implementation of appropriate risk mitigation strategies
· Lead quality input on contracts and serve as the primary contact for the negotiation of quality agreements; ensure that Quality agreements are complete, approved and updated at appropriate intervals.
· Provide guidance for investigations as well as corrective and preventive action (CAPA) plans for compliance issues and/or observations
· Remain current with quality management trends
· Establish a culture of compliance and collaboration by putting appropriate Quality processes in place
· Develop, manage and monitor adherence to the overall Quality and Compliance budget
· Develop, analyze and report quality key performance indicators and highlights
The role provides a unique opportunity to be an intricate part of shaping the pioneering path to a novel and compelling cell therapy product.
· Essential: BSc. or MSc. in protein engineering, biochemistry, molecular biology, cellular biology or related discipline
· Preferred: certified QP (Industry Pharmacist)
· Desirable: Additional study or training in project management
Other – essential
· Must have a minimum of 5 years of experience in pharmaceutical/biotech industry with increasing responsibilities, including 3+ years in a Quality function
· Experience establishing and/or enhancing development GxP quality infrastructure and systems compliant with
U.S. and international requirements
· Extensive knowledge of GMP, GCP and GLP including 21 CFR Part 11
· Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
· Strong interpersonal/communication skills. Prior success in working effectively with senior scientific, medical and operations staff.
· A track record of successfully managing external partners
· A track record of influencing key internal and external stakeholders to successful outcomes
· An appetite to work in a start-up company with a “roll your sleeves up” mindset
· Teamwork skills, effective and flexible attitude
· English fluency required with strong writing and verbal communication skills
· The role will be located at the Zelluna office in Oslo, Norway
Please send an application letter with your CV.
Zelluna Immunotherapy AS is a privately owned biopharmaceutical company founded in 2016 and is focused on developing transformative T cell receptor (TCR) guided natural killer (NK) cellular therapies for the treatment of solid cancers.
We are an experienced, dynamic and growing team that consists of highly engaged and motivated people all sharing the same vision:
“Saving life through innovative cancer targeted cell therapies”
- Ullernchausséen 64, 0379 Oslo
- Delvis hjemmekontor
- Farmasi og legemiddel,
- Forskning, utdanning og vitenskap
GMP GLP GCP, BSc. or MSc., Protein engineering biochemistry molecular biology cellular biology, Research and development, Quality systems
|2. jan. 2024 14:16