Sobi
Global Quality GVP Manager(m/w/x)
Vollzeit
Senior
Keine Angabe
Basel
ID
Idorsia Pharmaceuticals Ltd2 Monate
Global Senior Pharmacovigilance QA Manager(m/w/x)
Vollzeit
Senior
Keine Angabe
Basel
Nejo KI-Zusammenfassung
In this strategic role, you will enhance compliance in pharmacovigilance by leading audit programs, collaborating with stakeholders, and ensuring adherence to global regulations. Your expertise will drive policy decisions and foster a culture of quality across the organization.
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Anforderungen
- •Experience in Commercial GDP QA/Supply Chain QA
- •Strong background in Pharmacovigilance/Drug Safety and master's degree in relevant scientific discipline
- •Expert knowledge of international Pharmacovigilance regulations
- •In-depth knowledge of pharmaceutical industry practices
- •Experience in training employees on GVP requirements
- •At least 10 years of QA/industry/health authority experience
- •Prior experience in coordination of Pharmacovigilance inspections
- •Reliability, conscientiousness, and goal orientation
- •Excellent problem-solving and risk management skills
- •Ability to work independently and in a team
- •Excellent communication and interpersonal skills
- •Ability to establish collaborative partnerships and apply diplomatic skills
- •Fluency in English; knowledge of German and French advantageous
- •Experience in GDP, warehousing, and distribution of commercial products
- •Proficiency in Microsoft Office applications
Master-Abschluss
Berufserfahrung
10 Jahre von Vorteil
Deine Aufgaben
- •Lead and manage PV compliance audit programs
- •Ensure standardized PV approach across affiliate sites
- •Establish and maintain relationships with internal stakeholders
- •Provide expert-level PV knowledge and guidance
- •Lead key project initiatives across the organization
- •Offer strategic advice to stakeholders for policy decisions
- •Act as local PV QA Manager for affiliate sites
- •Support affiliates in implementing local PV systems
- •Maintain and improve a global PV QA audit program
- •Perform PV QA audits of vendors and affiliates
- •Track, record, and report audit results consistently
- •Identify and document corrective/preventive actions
- •Cooperate with EU QPPV and national Affiliate Safety Managers
- •Prepare for and follow up on inspections at Idorsia sites
- •Escalate significant PV compliance issues to senior management
- •Provide QA output to establish and maintain PSMF Quality section
- •Ensure inspection readiness of vendors conducting PV activities
- •Review archiving procedures at affiliate sites
- •Evaluate CAPA and deviation management procedures
- •Manage non-conformances related to GxP
- •Collaborate with HQ QA on documentation and training records
- •Plan periodic information exchanges on PV system topics
- •Stay updated on global pharmacovigilance regulations
- •Inform management about changes in country-specific PV laws
- •Review key global and local Quality System documents
- •Drive accountability for Quality and Compliance
Tools & Technologien
Microsoft Office
Sprachen
Englisch – verhandlungssicher
Deutsch – Grundkenntnisse
Französisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia Pharmaceuticals Ltd erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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