Translational Medicine G(C)lp Quality Lead

vor 1 Woche

Lausanne, Schweiz Hobson Prior Vollzeit

Hobson Prior are looking for a Translational Medicine G(c)LP Quality Lead to join a fantastic biotech establishment on a permanent basis located in Lausanne. Our client is focused on offer input to the community as well as the environment.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For this role, you will guide and partake in compound-specific regulatory authority inspections/due diligence actions.
- Participate in the development/upkeep of quality and translational medicine linked procedural papers.
- Form cooperative work relations as well as guarantee adequate communication within the business as well as the cross-functional quality colleagues.
- You will collaborate with the business shareholders to warrant appropriate CAPA development and follow-up.
- Assist with 'risk/impact assessments' connected to TM actions and respective suppliers partaking in SPO pre-clinical and clinical programs.
- Any other assigned duties.

**Key Skills**:

- Works well in a team environment.
- Communication skills both verbally and in writing.
- Ability to assist on various projects, duties, and assignments simultaneously.
- Capable of prioritising workload.
- Possess an independent way of working with the ability to assume ownership of allocated duties as well as plan and deliver rendering to approved deadlines.
- Capable of displaying multifaceted problems in a way that is comprehensible cross-functionally and with all levels of the business.
- Able to resolve issues and think analytically.

**Requirements**:

- Educated to a degree level in a scientific field or a corresponding amalgamation of experience and education.
- At least 7 - 10 years of experience within a pharmaceutical or biotechnology organisation with at least 5 years of experience in a quality management or regulatory compliance role.
- Know-how of GLP, GcLP, and regulatory guidance, which involves ICH, quality, non-clinical, clinical, multidisciplinary guidance documents and 21 CFR Part 11 compliance.
- Know-how of root-case analysis tools/strategies.
- Fluency in the English language with knowledge in French would be beneficial to the role.

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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