About the Company
Mereo is an international, clinical-stage pre-commercial biotech company with a focus on rare diseases. Founded in March 2015 to fund and develop high-potential novel therapies that were not being progressed in pharmaceutical or biotechnology companies.
Driven by a true understanding of the critical nature of our mission, we harness the power of science. With our knowledge of the rare diseases, we seek to create new possibilities for patients who need them and deepen relationships with all our stakeholders.
About the Role
We are seeking an experienced Head of Quality to lead our Global GXP Quality function. This is a pivotal role for a strategic and hands-on leader who will drive continuous improvement and quality management excellence across multiple locations as the Company grows. This role is based in our London office, near Oxford Circus underground.
Responsibilities
* Maintain a Quality Management System (QMS) encompassing all GCP, GMP, GDP, and PV aspects of the company’s operations, including any local Quality Systems required at Mereo affiliates.
* Identify and proactively address key quality risk areas within the company.
* Support and promote a positive quality culture across the organisation.
* Proactively influence GxP practices and performance of CROs and CDMOs working with these partners to ensure compatibility with the Company’s QMS and strategic goals, resolving any conflicts or gaps.
* Assess CRO systems, including IT security and resilience.
* Collaborate closely with the Head of CMC and Clinical Leadership to ensure the compliant and pragmatic operation of the QMS.
* Record and follow up on deviations and change controls within quality systems, including the implementation of CAPAs.
* Develop and maintain the annual GxP audit plan.
* Conduct or oversee audits, ensuring follow-up on findings.
* Provide practical quality consultation and advice on GxP matters to the organisation.
* Ensure Mereo remains GxP inspection-ready at all times.
* Deliver GxP training as needed and monitor staff training records.
* Oversee quality aspects of the Group’s IT systems.
* Liaise with counterpart Heads of Quality at Mereo’s collaboration partners.
* Line-manage the Quality Team.
Qualifications
* Minimum of a Bachelors degree, preferably in a scientific discipline.
Required Skills
* Strong experience and expertise across GMP, GDP, GCP, and PV QA.
* Proven ability to maintain a QMS and drive quality improvement strategies.
* Demonstrable experience in leading a GxP Quality Function.
* Minimum of five years’ auditing experience, primarily in vendor and trial site auditing.
* Strong risk and change management skills.
* Expertise in process mapping and development.
* Experience managing quality issues, including CAPAs, deviations, and complaints.
* Knowledge of computer systems validation (both operational and audit).
* Willingness to travel regularly.
* A solid understanding of the drug development process.
* Previous experience leading regulatory inspections within a biotech environment.
Preferred Skills
* Experience in developing and delivering GxP training.
* Familiarity with Veeva Quality Vault.
Pay range and compensation package
* Competitive salary and benefits package.
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