Clinical Development Quality Lead
This vacancy has now expired. Please see similar roles below...
Hobson Prior are currently seeking for a Clinical Development Quality Lead to join a fantastic biopharmaceutical corporation on a permanent basis located in Lausanne. For more information, please get in touch now!
Please note that to be considered for this role you must have the right to work in this location.
- For this position, you will guide/partake in compound-specific regulatory authority inspections/due diligence actions.
- Offer compliance assistance and participate in "in process/ongoing" oversight via review and follow-up on reported quality events possibly jeopardising the validity of the clinical study.
- Implement the risk-based approach, recognise the requirements to and perform co-auditing actions/quality visits with DPI and/or CRO representatives.
- Supply constant compliance assistance by serving as an internal advisor on pertinent processes and guidelines to guarantee correct comprehension and suitable execution.
- Produce KQI to recognise areas for improvement based on risk-based compliance actions and audit observations.
- Offer audit/CAPA assistance to the implementation of master audit plan applied, support the DPI business shareholders to guarantee suitable CAPA formulation and follow-up.
- Supply assistance to the development/upkeep of QM and ClinDev linked procedural documents.
- Any other assigned duties.
- An organised individual with the ability to adapt, be rigorous and flexible.
- Focused on effectiveness and constant improvement.
- Able to think tactically.
- A high attention to detail.
- Communication skills both verbally and in writing.
- Educated to a degree level in a scientific field or similar.
- At least 6-8 years of experience within a clinical environment in a pharmaceutical/biotech organisation, which involves at least 3 years in a clinical quality management system and compliance role.
- Familiarity with handling and performing GCP audits such as CROs, TMF, Investigational Sites and CSR.
- Expertise on GCP, CFR Title 21 and regulatory guidance which involves, ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance.
- Acquaintance within the mechanism of various QA vendors oversight.
- Past involvement in setting and updating SOPs.
- Know-how of computerised systems validation.
- Fluency in the English language with knowledge in French would be beneficial.
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.
€40000 - €50000 per annum
Cork, Republic of Ireland
Hobson Prior are currently looking for a Principal QA Representative to join a brilliant biopharmaceutical organisation on a permanent basis located in Cork.
£115000 - £125000 per annum
Hobson Prior are looking for a Director Clinical QA to join a brilliant biotech organisation on a permanent basis located in London.
Up to £85000 per annum
Hobson Prior are currently looking for an Associate Director/Director GCP QA to join a brilliant pharmaceutical organisation on a permanent basis located in the UK.
£50000 - £60000 per annum
Hobson Prior are currently looking for a QA Specialist to join a brilliant pharmaceutical organisation on a permanent basis located in Baden-Wurttemberg.
£40000 - £50000 per annum
Hobson Prior are currently looking for a Quality Assurance Manager to join a brilliant pharmaceutical organisation on a permanent basis.
CHF120000 - CHF130000 per annum
Hobson Prior are looking for a Manager QA/EU QP Deputy to join a fantastic pharmaceutical organisation on a permanent basis.
Shannon, Republic of Ireland
Hobson Prior are looking for a QA Validation to join a fantastic biotech organisation on a permanent basis located in Shannon.