Quality Assurance Director

Location
Germantown, Maryland
Salary
Salary commensurate with experience
Posted
Jun 16, 2022
Required Education
Bachelors Degree
Position Type
Full time

The Company

 

Vaccitech plc is a fast-growing biotech company. At only six years old we already have a development portfolio of nine programmes, a partnered product that is in commercial production which 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 and cancer. 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 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 US operational presence in Maryland, complements Vaccitech’s established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. In March 2022 Vaccitech's UK headquarters relocated 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

 

Reporting to the Chief Operating Officer, the Director of Quality will lead the Quality Assurance function for Vaccitech North America. They will input into development plans and programs to ensure appropriate Quality strategies are executed in accordance with the overall development plans, ensuring good practices (GxP) are adopted and implemented throughout the organisation. You will maintain detailed working knowledge of the Quality environment through direct and indirect contact with agencies and industry groups including the FDA. You will also ensure Quality compliance and take accountability for ensuring Vaccitech maintains its ‘Inspection Ready’ status. You will provide Quality expertise and oversight internally to project teams and other departments. You are responsible for maintaining a constant and current knowledge of global Quality intelligence, advising the business of any potential impacts with regards to changes in regulations and guidelines and recommending appropriate course of actions. You will prepare and manage the Quality annual budget in North America, working with staff, external consultants and advisors to communicate effectively to ensure Vaccitech maintains ‘Inspection Ready Status’ at all time. You will also Maintain and develop the QMS to ensure ongoing compliance with regulatory standards and regulations.

 

Experience and qualifications

 

The successful candidate will be degree educated and have a proven track record in leading a quality assurance function in the pharmaceutical, biotechnology or life science industry. You will have operated at a strategic level in your career, being involved in Gap analysis plus the design and build of quality systems. The successful candidate must have experience working for a small molecule manufacturer with detailed knowledge and experience of GMP. GCP knowledge is desirable, though not essential. Willingness to undertake some travel, especially to the UK Headquarters from time to time is required (it is envisaged that this would be about 4 trips to the UK Headquarters/year at a frequency of no more than once every 2-3 months).

 

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 is a strategic leadership role within a fast growing business that will give the successful incumbent bandwidth to design the future direction of the quality function in Vaccitech. We offer employer funded health, dental and vision insurance, a 401k retirement plan, career development opportunities and paid time off (PTO). Salary will be commensurate with experience.

 

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 enquiries 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.