We are growing, grow with us!
We are looking for an independent consultant to develop a temporary project in one of our clients
Location: Rhein Main area in Germany
Working hours: the consultant may not necessarily be on site 5 days/week but would preferably be within commutable distance
Global Vendor Compliance Manager
- Conduct of Vendor assessments and pre-qualification visits
- Author of Quality Management Agreements (as part of the contracts) Ensures Quality Oversight
- Escalation of issues and NC/CAPA Support
- Quality Medicine representative on relevant Vendor Governance Councils Supports inspection readiness and management
- Consultancy and guidance for GxP topics
- Implements Standard list of SOPs and standard language in vendor contracts.
- Ensures archiving of vendor specific information.
- Ensures collection and review of quality metrics for assigned vendors (based on risk assessment).
- Evaluates vendor quality management processes and initiate improvements where/when needed.
- Escalates quality issues as applicable.
- Clear responsibilities for inspection preparation, conduct, follow up and agency response are defined and followed
- Availability for information and documents (incl TMF) is ensured.
- Represents Quality Medicine in global vendor committees
- Supports business during selection processes, including pre-qualification visits. Gives guidance and support
Your ProfileVocational training, Education :
Primary degree in Lifesciences, Advanced degree preferred
Minimum 10 years working in the Pharmaceutical industry, Quality Assurance management experience required with previous experience leading vendor compliance activities.
International Medicinal Product Regulations, GxP guidelines, Qua lit y Management Systems, Third Party Oversight, Quality Technical Agreements and Quality Risk Management.
Vendor Compliance Management, Vendor Qualification, Vendor Auditing, Quality Systems Management, Quality Operations Management and Quality Metrics.
Excellent Communication and Organisational abilities, Leadership in Quality Management, Team Orient ed and Drive for results.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.