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.
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
- 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.
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.