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Director - Head of Quality Assurance

Introduction

Enara Bio™ (formerly known as Ervaxx) is a science-led company leveraging its proprietary discovery platforms to deliver targeted cancer immunotherapies designed to treat a broad patient population. Enara Bio is exploring the hidden depths of cancer and T-cell biology to discover and characterize novel, shared immunotherapy targets such as Dark Antigens™ and HLA-independent ligands. We are pioneering approaches to exploit these targets with a TCR-directed T-cell immunotherapy product pipeline.

Job Summary

Enara Bio is expanding its CMC footprint within the organisation, to deliver a pipeline of Cell and Gene Therapy products, including autologous ex vivo gene modified TCR-T therapeutics to patients with cancer. We are now looking for an experienced Head of Quality Assurance, to lead the efforts of designing and implementing a pharmaceutical Quality System.

You will be expected to:

This role is responsible for designing a fit for purpose and fully compliant GxP quality system to support our transition from a research focus to manufacturing, release and distribution of our clinical trial material for first-in-man studies, together with external collaborators.

The successful candidate will be responsible for embedding Enara Bio’s quality mindset through to the architecture of a QA system to meet the needs of a Cell Therapy company transitioning from Research into clinical trials. This role will require an individual with previous experience of;

  • Setting up a quality system from scratch to meet GxP requirements ideally within the cell and gene therapy field
  • Working collaboratively as this is the first role of this kind within Enara
  • Embedding a quality mindset across a growing organisation with a focus of mitigating risk to our patients i.e. Patient safety is our number one priority
  • Writing SOP’s and other relevant GxP documents
  • Selecting an appropriate QMS, DMS, LMS solutions including tools to manage complaints, CAPA’s, Deviations, change controls and specifications
  • Identifying and qualifying external collaborators by taking part in the selection process as well as associated regular audits and maintaining the collaboration relationship
  • Leading inspections and audits from external parties

Key Responsibilities

  • Building a quality culture and mindset that is meeting the company’s stage of development and culture of collaboration.
  • Assuring appropriate oversight of external (GxP) activities, including vendor qualification, contributing on Quality Agreements, performing audits and tracking CAPA follow-ups.
  • This role will be predominantly focused on educating and mentoring various members of the team on the journey from Research into a regulated landscape as we evolve.
  • Working closely with functional leadership and representatives to ensure alignment and coordination across priorities.
  • Assisting and reviewing / approval of source documents that will go into regulatory filings.
  • Responsible for oversight of External collaborations with GxP vendors to assure on-time, compliant documentation and batch release.
  • Demonstrating leadership of their breadth of professional experience and the drive to work with both internal and external partners to define and implement effective Quality assurance.
  • Be the lead and Quality representation during any GxP audits/inspections by health authorities.

Must have the ability to work in a highly matrixed and cross-functional organization, against tight deadlines, and with world-class partners, suppliers and business leaders alike

Minimum Qualifications and Experience required

  • Proven track record in setting up stage appropriate, Cell therapy suitable Quality Management systems is a must.
  • Excellent interpersonal, communication, and presentation skills.
  • Cell Therapy experience.
  • Strong knowledge of biopharma industry. Familiarity/experience with end to end CMC drug development and clinical Manufacturing.
  • Degree in Life Sciences or related discipline.
  • Advanced degree in Life Sciences-related discipline strongly preferred.
  • Certification / Eligibility as EU QP and qualified GxP auditor required.
  • Ability to work cross-functionally, with matrixed teams; maintaining strong business partner relationships.
  • Strong leadership skills and executive presence; ability to positively influence outcomes.
  • Expertise in conflict resolution.
  • Excellent critical thinking and problem-solving skills.
  • Willingness to do what needs to be done in a dynamic environment.
  • Experience working in global setting.

Further information

The Enara Bio team is driven to make a meaningful difference for people affected by cancer. Our culture is defined by our behavioural ethos:

  • Act with unconditional positive regard and integrity
  • Support each other to grow and develop
  • Promote a collaborative, passionate and fun working environment
  • Innovate by discussing issues, data and ideas openly
  • Respect each other and value our diversity
  • Embrace our shared goals and take ownership of our journey

We offer a competitive salary, commensurate with qualifications and experience, and a benefits package including pension and health insurance.

Applicants should be able to demonstrate proof of the right to work in United Kingdom.

Enara Bio Limited is an equal opportunities employer.

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Job Reference: 432548