Proclinical are in search of a GxP Compliance Manager to support the Quality and Compliance team. The post holder will double down as the 'Responsible Person' managing the Portugal Region, overseeing the implementation and execution of the Corporate Quality System.
- Support the roll out and on-going compliance to the global quality and compliance systems, and associated procedures and standards to the responsible cluster.
- Ensure that Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GDP, GXP and PV guidelines.
- Support the assessment of compliance on a regular basis.
- Ensure the company is kept fully informed of new or emerging GMP and regulatory changes in the region.
- Support the implementation of Quality Improvement/remediation plans for the Affiliate identified through Corporate as well as internal GDP/GXP/PV audits.
- Monitor GDP, GXP and Pharmacovigilance compliance to regulations, procedures and communicate CAPAs and action plans to Country Management and Corporate Quality.
- Support the local operational daily business and activities.
Skills and Requirements
- A Life Science field degree.
- At least two years of experience within a Quality function with GCP within pharmaceuticals, biotechnology, or CRO.
- Fluency in English and German.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.