Global Qualität Assurance Manager (m/f/d) — Coopers Group AG
NeuCHF 85'500 - 129'500
Coopers Group AG · Basel-Stadt (BS)
- Ort
- Basel-Stadt
- Vertrag
- contracting
- Veröffentlicht
- vor 4 Tagen
LohnCHF 85'500 - 129'500
Rollenüberblick
position is instrumental in safeguarding product quality and regulatory compliance for global clinical trials.
You will utilize your expertise in quality systems and supply chain distribution knowledge to provide guidance and maintain oversight over complex GxP processes.
Location: Basel Duration: 1 year/possible extension An exceptional candidate holds a Bachelor's degree in a relevant scientific or technical field and brings a minimum of three years of comprehensive Quality Assurance experience deeply rooted in a regulated GMP/GDP environment.
- position is instrumental in safeguarding product quality and regulatory compliance for global clinical trials.
- You will utilize your expertise in quality systems and supply chain distribution knowledge to provide guidance and maintain oversight over complex GxP processes.
- Regulatory Compliance: Act as the appointed Delegate of the Swiss Responsible Person (FvP), providing necessary final Quality decision-making
- Global Oversight: Maintain Global QA oversight for the entire IMP Distribution Network and its business counterparter PTDS-L.
- Life Sciences - Quality Management Basel-Stadt Contracting Full Time
- As soon as possible - 1 year after start date Quality Assurance, GxP, Compliance
Hauptaufgaben
- Regulatory Compliance: Act as the appointed Delegate of the Swiss Responsible Person (FvP), providing necessary final Quality decision-making
- Global Oversight: Maintain Global QA oversight for the entire IMP Distribution Network and its business counterparter PTDS-L.
- Lead the Deviation Management process by performing product quality impact assessments.
- Provide crucial Quality oversight by reviewing and assessing final evaluations and statements from third parties, ensuring consistency with regulatory standards, and checking if proposed Corrective and Preventive Actions (CAPA) are appropriate.
- System Owner: Manage the full lifecycle of quality documentation and Change Records, including establishing, reviewing, and approving critical documents and changes for both internal procedures and external business documents (PTDS-L).
- Inspection Management: Actively drive and support all GxP inspections and audits.
- Quality Decision-Making: Manage Temperature Excursion Management for clinical trials, including performing assessments and managing Expert Statements/Opinions.
- Support clinical studies by reviewing and approving IMP Supply & Release Flowcharts, Transfer requests, and Expert Opinions.
- Establish and approve Master Quality Agreements and Quality Agreements.
- Manage Complaint Management for clinical trials.
Wichtige Anforderungen
- Life Sciences - Quality Management Basel-Stadt Contracting Full Time
- As soon as possible - 1 year after start date Quality Assurance, GxP, Compliance
Weitere Details
- Support quality-related and business-driven projects within the IMP Distribution network. Drive continuous improvement activities
Notizen und Originalinhalt
- Responsibilities:
- Support quality-related and business-driven projects within the IMP Distribution network.
- Drive continuous improvement activities
