Associate Director/Senior Manager, Clinical QA
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Proclinical are recruiting for an Associate Director/Senior Manager, Clinical QA to join a biotech organisation. This role is on a permanent basis with the ability to work remotely from anywhere in the UK.
- Partake in the quality mission to both design and develop a single, fit for purpose QMS.
- Perform GCP procedure, vendor, and investigator site audits.
- Responsible for quality evaluation of GCP essential records.
- Assist on GxP Quality requirements in development & precision functions such as GVP, GLP, GDP/GMP & CSV.
- Offer GCP expert advice and leadership to project/study teams.
- Raise compliance risks/concerns to senior management.
- Other duties may be assigned.
Key Skills and Requirements:
- Demonstrable experience in GCP quality within a biotech/pharma which spans clinical trial phases I to III.
- Knowledge in GCP international guidelines and regulations such as ICH E6, ICH E8, EU CTR, FDA CFRs, etc., as well as present GCP industry best practices.
- Know-how of any other GxP regulations & guidance would be advantageous such as GVP, GLP OECD, GMP/GDP PICS, & CSV.
- Prior involvement in auditing cross various typed of GCP audits such as CRO, phase I, investigator sites, essential records, process/system audits).
- Auditing, conduct/exposure in GVP, GLP such as labs/CROs, CSV, and GMP/GDP would be beneficial to the role.
- Familiarity with contributing to regulatory agency inspections, such as MHRA, FDA, EMA as well as displaying quality metrics/analytics.
- Able to present efficiencies to QMS such as Policies, SOPs, Working Instructions, etc. aligned with Quality mission to develop a single, fit for purpose QMS across GxP regulated areas.
- Educated to a degree level in a life science or healthcare linked field.
- Interpersonal and communication skills both verbally and in writing.
- Work well with others in a team.
- Capable of taking accountability for distributing quality & development, projects & initiatives via cross-functional influence.
- Able to think 'outside the box' to recognise risks/challenged and distribute creative solutions.
- An international and tactical mindset with the ability to work under minimal/no supervision.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.