Director, Clinical QA
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Hobson Prior are looking for a Clinical QA Director to join a brilliant pharmaceutical organization on a permanent basis located in Munich. Our Client is dedicated to transforming the practice of medicine by achieving the impossible.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will ensure compliance with GCP through a Quality System.
- Creating a quality assurance strategy that aligns with the objectives of the company.
- Provide adequate resources to the QA department at all times.
- Manage and direct the QA team to ensure their professional development and motivation.
- Implement a change control system that is effective and efficient.
- Perform internal audits on the QMS as well as documents (e.g. protocols, ICFSs, CSRs).
- Oversee and conduct external GCP audits of investigator sites, CROs, other GCP vendors as required by GCP.
- Ensure audits, CAPAs, change control or deviations are followed up on and resolved.
- Ensure preparation of GCP QA inspections with the support of the Quality VP.
- Inspect sites with the Regulatory Authority on a regular basis.
- Stay up-to-date on all FDA/EU/other international quality assurance regulations and laws.
- Review of GCP risks and opportunities for process improvement on a continuous basis.
- Ensure GCP training and GLP/GCLP training is provided as necessary.
- A strong team player and self-starter with a strong work ethic.
- Analytical skills with the ability to consider future effects when solving problems.
- The ability to work independently.
- Experience building and managing high-performing teams.
- A minimum of 10 years of experience in a GCP-related field - with a strong background in managing clinical studies and preparing for inspections.
- Expertise in ICH GCP and in national and international regulations (mainly EU and US).
- CRO and Sponsor experience, as well as GCLP and bioanalytical experience, would be advantageous.
- An undergraduate degree in the life sciences, medical/pharmaceutical sciences, or a similar field.
- An excellent command of the English language, both written and spoken.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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