Join to apply for the Head of Quality role at Mestag Therapeutics
At Mestag we truly believe in our values and live by them every day. We’re ambitious about our science and its potential to deliver meaningful therapeutics to the patients that need them most. We believe in a culture of diversity, equality and investing in people to ensure our talented and passionate team members can fulfil their full potential.
We are based in spacious and modern laboratory and office facilities at Chesterford Research Park near Cambridge, UK – right in the very heart of the UK life science sector. Our facilities are kitted out with state-of-the-art instruments to enable our dedicated researchers to deliver incredible science.
Mestag is backed by committed leading global investors, has world-class founders and a highly experienced leadership team.
We are now transitioning our lead programme into clinic - There has never been a better time to join #TeamMestag
Scope of role
This is an outstanding opportunity for a proactive and enthusiastic Senior Quality professional to join our team in an innovative biotech to work closely with cross‑functional teams both internally and externally.
With our lead compound transitioning into clinic, we are looking for a highly collaborative Head of Quality with passion and motivation to lead and define our Quality and Compliance activities including defining our quality processes and procedures to ensure the organisation remains in compliance with appropriate clinical trial and pharmaceutical regulations and guidance, and in a state of “inspection‑readiness”.
In addition, the Head of Quality will together with the R&D leadership ensure that quality standards are for the internal research activities.
This is an exciting hands‑on role working within a fast‑paced biotech environment and you will experience a variety of broader business activities including business development, portfolio reviews, staff/system developments, and strategic reviews and share our vision to bring new therapies to patients in need.
The Position
* Review and maintain the Quality Management System
* Ensure necessary procedures are prepared and implemented successfully
* Oversee Quality Training Records, Deviations, Change Control and CAPA systems and compliance with associated SOPs and GxPs
* Contribute to the establishment and management of supplier contracts & management of supplier performance, implement an assessment and audit programme, ensure adequate monitoring of such
* Establish a network of external auditors, regulators, and expert contacts to support decision making in quality related matters
* Oversee Sponsor Oversight audits and assessments for GxP suppliers and critical sub‑contractors
* Assist in the identification and classification of Quality Incidents/complaints based on the company’s outsourcing business model and lead the progression and completion of quality investigations when issues occur at external vendors
* Contribute to the compilation and approval of technical documents, expert reports, etc., to support development, manufacture, supply, clinical development and safety assessment activities
* Implement a self‑inspection programme. Conduct internal and external audits (including mock inspection/s). Assist in the progress of action items as indicated in any audits to ensure they are satisfactorily closed within the committed time frame
* Support clinical study and programme level risk management activities
* Ensure GxP training is provided to relevant staff on a regular basis
* Build and provide leadership, coaching and guidance to the QA Team to achieve program and organizational goals
* Establish and maintain, with the R&D leadership team, the necessary quality standards for internal (non‑GLP regulated) lab work
* Contribute to a collaborative environment with Mestag core values of Passion, Boldness, Integrity and Teamwork driving innovation and efficiency within the team
Minimum Qualifications and Experience
* Extensive experience within Pharmaceutical Quality Assurance ideally with experience of working within a developing fast paced R&D based biotech company at a director level
* BSc, MSc or PhD within a scientific discipline, ideally within Chemistry, microbiology, pharmacy or biotechnology
* Expert knowledge of current GMP and GCP regulations and guidance in EU, UK and US
* Familiar with Good Pharmacovigilance Practice (GPvP) and Good Laboratory Practice (GLP)
* Demonstrates excellent written and verbal communication and presentation skills
* Demonstrates excellent organisational skills, the ability to work to deadlines and, multi‑task
* Highly collaborative, strong relationship building skills with a high level of integrity
* Competency in Microsoft Office suite, ideally including experience using MS Project or Smartsheet
* Ability to assess and manage risk
* Passionate, self‑driven, dedicated, inclusive, open‑minded, collaborative and forward‑thinking
* Ability to work independently, yet co‑operatively with others in a dynamic fast‑paced environment; genuine desire to be a part of a team and contribute to organizational and team goals
In return we can offer you
We work flexibly with a strong team spirit and offer a highly competitive total rewards package including competitive salaries, pension contributions, private medical insurance, income protection and more.
We have access to a range of onsite facilities including a gym, canteen, golf course and free on‑site parking.
As a team we achieve great things each day, and we take the time to celebrate successes, share and learn. We value the relationships of our close‑knitted team and strive to make meaningful connections in our community. We frequently hold Town Halls and team lunches, and have an active social committee, organising regular events and ‘giving back’ activities supporting charities close to our hearts.
About Mestag Therapeutics
Mestag harnesses new insights into fibroblast‑immune interactions to develop impactful treatments for patients. We are progressing a pipeline of sophisticated first‑in‑class antibodies designed to improve the lives of patients with cancer and inflammatory disease. Together with our collaboration partner we are also identifying novel targets for future therapies.
Our founding investigators comprise global experts in inflammatory disease, cancer, computational biology and fibroblast biology from the University of Oxford, Brigham & Women’s Hospital, Harvard Medical School and Cold Spring Harbor Laboratory. We are supported by leading life science investors SV Health Investors, Johnson & Johnson Innovation – JJDC, Inc., Forbion, GV (formerly Google Ventures) and Northpond Ventures.
Mestag is headquartered in Cambridge, UK, and in 2021 was recognized on the Fierce 15 list of innovative biotechnology companies.
For further information please visit our website www.mestagtherapeutics.com
Recruitment process
This recruitment process is being managed by Simon Wright at SJ Sourcing. For further information, or to apply for the role please contact Simon on simon@sjsint.com.
Seniority level
* Director
Employment type
* Other
Job function
* Quality Assurance
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