Clinical Development Quality Lead

vor 2 Wochen

Lausanne, Schweiz Proclinical Vollzeit

Proclinical are recruiting a Clinical Development Quality Lead for a pharmaceutical organisation. This role is on a permanent basis and is located within Europe. The client is focused on improving the quality of people's lives.

**Responsibilities**:

- Guide/partake in compound-specific regulatory authority inspections/due diligence actions.
- Offer assistance to the development/maintenance of QM and ClinDev connected procedural documents.
- Implement the risk-based approach, recognise the necessity to and perform co-auditing actions/quality visits with DPI and/or CRO representatives.
- Produce KQI to recognise fields for improvement based on risk-based compliance actions and audit observations.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to a degree level in a scientific field or pertinent academic background.
- At least 6-8 years of experience within a clinical environment of a pharmaceutical/biotech organisation, which involves at least 3 years of experience 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.
- Present know-how of GCP, CFR Title 21 and regulatory guidance's including, ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance.
- Acquaintance with the mechanism of various QA vendor's oversight.
- Prior involvement in setting as well as updating SOPs.
- Know-how of computerised systems validation.
- An organised individual who is rigorous, flexible and able to adapt to changing circumstances.
- Focused on productivity and continuous improvement.
- Able to think tactically and keep a general view while bringing productivity to day-to-day detailed actions.
- Fluency in the English language with knowledge in French would be beneficial.

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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