Clinical Development Quality Lead
vor 1 Monat
**Salary**:
CHF140000 - CHF150000 per annum**Job type**:
Permanent
**Location**:
Lausanne, Switzerland
**Function**:
Quality Assurance, Quality Systems
**Posted**:20/06/2023
**Ref**:
BBBH22811
- Hi I'm
Ingrid
, I manage this role
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.
**Key Responsibilities**:
- 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.
**Key Skills**:
- 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.
**Requirements**:
- 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.
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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