Description
We are looking for a
Compliance and Quality Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Ensure staff are trained according to company standards (e.g. codes, policies, directives, guidelines and SOPs), industry codes and applicable legal and regulatory requirements
- Co-ordinate the learning management system together with the pharma healthcare compliance office
- Implement quality management processes and procedures to improve the accuracy or timelines of its output, or to meet established standards (e.g. compliance checks)
- Develop and maintain quality standards and metrics for key activities
- Active review of audit reports (PDQ and GARA), and monitor the CAPAs implementation plans of audit reports to improve standards and processes
- Provide compliance support by being the functional representative and bring issues to the attention of the leadership team members as appropriate
Your qualifications
- University degree, preferably in life sciences/biology/medicine or another healthcare discipline
- An outstanding professional experience within the pharmaceutical industry, preferably in a compliance/quality related function at a local, regional or global level
- In-depth knowledge of GVP, healthcare and medical compliance, SOPs and regulatory requirements
- Experience in quality risk management/quality management system and/or compliance management system
- Strong analytical and decision making skills in a complex, fast paced, and changing environment
- Pharmaceutical industry knowledge and understanding/experience with drug discovery and commercialization processes
- Fluency in English, in both oral and written form
Skills:
- Compliance manager