CLINICAL QUALITY MANAGER
OXFORD | FULL TIME
The opportunity has arisen for a person to work in a young biotech company, reporting to Chief Medical Officer and working closely with the development teams, to deliver all the clinical quality needs, across the various company verticals in respiratory, infectious diseases and regenerative medicine/wound healing, supported by good preclinical and clinical data already achieved with the company’s primary nitrite/nitric oxide technology. This is an opportunity to be part of a very exciting team at an early stage of its journey.
New lead role in Clinical Quality in a start-up biotech company, aiming to start PI/II clinical trials in approximately one year.
Key goal will be to build pharmaceutical medicine quality management system (QMS); experience with both paper and electronic systems would be ideal.
Develop all standard clinical SOPs to support the whole organisation.
Focus will be on establishing and maintaining GCP processes/procedures, clinical quality standards and requirements.
Provide key internal clinical quality audits according to relevant GCP and regulatory standards.
Help to select and audit key Suppliers/CROs.
Providing internal training on quality systems, procedures and GCP.
Key support for any MHRA audits (eg GCP, PV) and FDA audits, when they arise.
This is a great opportunity for a clinical quality professional to join a progressive, dynamic and developing company.
A Clinical Quality professional with experience of setting up and maintaining a suitable QMS to support all normal clinical activities.
Prior experience with developing all standard clinical SOPs is important.
Fundamental to this role is experience in contributing to all clinical quality matters leading to regulatory submission, clinical protocols, conduct of clinical trials and their reporting, according to all regulatory and GCP standards.
Understanding and wide experience of GCP/ICH and clinical quality requirements/standards is essential for this role.
Working closely with clinical development/operations, project management and regulatory will be essential to deliver all necessary quality procedure/processes, checks and standards.
Experience with helping to select and audit CROs to conduct clinical trials is important, as is auditing of vendors and investigator sites.
Experience with supporting MHRA audits (eg GCP, PV) and ideally FDA audits would be an advantage.
Experience of quality checks, selecting and audits of Suppliers and CROs.
Experience providing internal training on quality systems and GCP.
This position would ideally suit an experienced Clinical Quality professional (>5 years) with recent active QMS development experience, looking to forward their career and progress clinical quality in a number of novel areas.
Experience and comfort in working in a small biotech/pharma environment is important.
Excellent communication skills and an open and positive approach to working with development teams and across the whole business would be ideal.
Going forward, there are plans for further expansion, and so the successful candidate will possess not only the core skills to ensure success in the immediate challenge, but also the flexibility and head room to grow with the business as it progresses to the next stage.
The role will initially have no direct reports but this is likely to change as the company moves into its first clinical trials in the next 12 months or so.
Comfortable working in a relatively flat structure is also important.
The new hire should also have a pragmatic mind set, capable of being entrepreneurial where appropriate, despite being responsible for all key clinical quality matters.
Self-starter and energetic.
Commitment and responsibility.
Good team player.
Effective internal and external communicator.
Open-minded and ability to listen to colleagues.
LOCATION & REMUNERATION
The position will be based most of the time at the new R&D Office near Oxford (Milton Park), with possibly weekly visits to the 30 Technology London office.
Occasional flexible home working (up to 1 day per week) may be possible after reaching the probation period of 3-6 months.
The company offers a package commensurate with the role. Given the potential for long term growth of the business, this is a role that offers significant upside potential.
To be considered for this exciting opportunity, please submit your CV and a cover letter to email@example.com
Closing date: 31st October 2019
30 Technology is an equal opportunity employer. All applicants will be considered for employment without attention to race, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
30 TECHNOLOGY is developing and defining new models of care to treat many serious medical conditions by enhancing the body’s healing and defence mechanisms.