Document Controller and Veeva System Administrator Harwell, South East England, England
Job description
Vaccitech plc is a fast-growing biotech company. At only six years old we already have a development portfolio of nine programmes, including a partnered product that is in commercial production and that has seen more than 3 billion doses administered worldwide and an IPO behind us. We are a publicly listed clinical stage biopharmaceutical company that spun out of the University of Oxford's Jenner Institute, one of the most prestigious vaccine research centres in the world. We discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases, cancer, and autoimmunity. Our achievements include co-inventing and jointly developing our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. We run clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for our platforms.
In December 2021, Vaccitech acquired Avidea Technologies Inc. with exciting product candidates for oncology and autoimmunity based on the innovative SNAPvax platform, which has demonstrated unprecedented control over T cell induction. This gives us U.S operational presence in Maryland, complements Vaccitech's established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. Vaccitech's UK headquarters has recently moved to a state-of-the-art facility in the UK's leading science and innovation campus at Harwell. We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.
The role
The Document Controller will be the Systems Administrator for the company's global electronic Quality Management System (eQMS), Veeva, currently used for document management and training. This person will also be responsible for helping with the implementation and administration of further Veeva Quality System modules such as Quality Events, CAPAs and Change Control. The Document Controller will report to the Director of Quality Assurance.
We are looking for an individual that is self-motivated and willing to own their own training and development, which includes liaising with Veeva support staff. The person needs to be inquisitive, and solution focused and willing to train other employees.
This person needs to be computer literate with a strong interest in learning new computer systems and finding out how they work.
Key areas of responsibility will include, but are not limited to:
- Serve as Subject Matter Expert (SME) for Veeva Vault and to act as the company's Administrator for Veeva.
- Provide oversight and support to the Director of Quality for Vaccitech's global quality system, supporting both North America and the U.K.
- Support Quality Systems governance of Quality Events (i.e., deviations, non-conformances, etc.), CAPAs, Change Controls and Quality Metrics.
- Review and approve document change controls and procedures, which include, but are not limited to: SOP's, policies, controlled forms, and templates.
- Creation of training curricula within Veeva.
- Generate and revise SOPs and associated documents, including templates as needed, including oversight of SOP biennial review compliance.
- Capture metric information for use in continuous improvement of areas of responsibility and report to management, as needed.
- Archive (or oversee the archiving) documentation on behalf of the Quality Department.
- Perform or assist training on QA topics to the organisation to include staff induction training and Veeva.
- Manage Veeva general releases and refreshes of the Veeva environments.
- To be the main liaison between Vaccitech and Veeva.
Qualifications and/or experience required to perform the role
- Previous experience in working in a highly regulated environment such as biotechnology, pharmaceuticals, or medical devices.
- Experience in electronic Quality Management Systems, Document Management Systems, and Training Management Systems. Highly desirable is previous experience with Veeva.
- Highly motivated with a positive attitude.
- Good communication skills and ability to work well with others.
- Previous experience/ roles requiring strong computer skills and learning new computer systems.
- Experience in training others in computer systems is desirable.
What we can offer you
Vaccitech is a great place to work. We encourage an entirely flat structure with an open-door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. This role would suit an experienced QC Chemist who wants to move into a QA career path. As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. We offer flexible forms of hybrid working, stock options to all employees, 25 days annual holidays increasing with length of service, an AXA Healthcare plan, Life Insurance and up to 6% pension contributions matched by the company.
Notice to recruiters
Vaccitech's internal Talent Acquisition leads recruitment and employment for Vaccitech. Unsolicited resumes sent to Vaccitech from recruiters do not constitute any type of relationship between the recruiter and Vaccitech and do not obligate Vaccitech to pay fees should we hire from those resumes. Vaccitech operate a preferred list of recruitment suppliers, any and all equiries about joining us as a supplier should be directed to Vaccitech's TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees.
