Quality Manager in Cancer Research Company

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.

Key Responsibilities

·        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.

Basic requirements

Academic

·        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.