Associate Director/Senior Manager, Clinical Qa

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.

Responsibilities:

• 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 j.godden@proclinical.com.

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.

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