Idorsia
Senior QA Compliance & Auditing Manager (GMP/GDP)(m/w/x)
Vollzeitnur vor OrtSenior
Allschwil
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Leading commercial pharmaceutical artwork projects, managing lifecycle from initiation to market deployment. 7+ years in pharmaceutical QA/compliance required. Coordination of artwork development with translations and proofreading.
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Anforderungen
- University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or relevant scientific discipline (Master's preferred)
- Minimum 7 years in pharmaceutical Quality Assurance, Compliance, Supplier Quality, Manufacturing Quality, or related GxP functions
- Experience managing supplier qualification programs and conducting GMP/GDP audits as Lead Auditor
- Strong knowledge of pharmaceutical development, manufacturing, packaging, testing, storage, and distribution
- Excellent knowledge of relevant GMP/GDP regulations and international quality standards (EU GMP, EU GDP, ICH, PIC/S, WHO, FDA, ISO)
- Ability to independently interpret regulations and implement pragmatic, risk-based compliance solutions
- Experience developing and managing Quality Agreements and external partner oversight programs
- Strong project management skills, managing multiple priorities in dynamic environment
- Excellent analytical, organizational, and problem-solving capabilities
- Confident, proactive, and capable of influencing stakeholders at all organizational levels
- Strong interpersonal, communication, and leadership skills
- Knowledge of other GxP areas (Pharmacovigilance, Clinical Quality, CSV, Data Integrity) is a strong advantage
- Fluent in English; knowledge of another European language is an asset
Aufgaben
- Lead commercial pharmaceutical artwork projects
- Manage artwork change for product launches and regulatory submissions
- Own the artwork lifecycle from initiation to market deployment
- Coordinate artwork development with translations and proofreading
- Develop and maintain project plans and timelines
- Lead cross-functional governance and approval meetings
- Support commercial packaging for product launches
- Manage relationships with artwork agencies and suppliers
- Ensure compliance with regulatory and serialization requirements
- Track and communicate project status and risks
- Coordinate artwork-related documentation and change controls
Berufserfahrung
7 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – fließend
OTHER_EUROPEAN – Grundkenntnisse
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia 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.
Zur Originalanzeige bei IdorsiaÜber das Unternehmen
ID
PharmaceuticalsAllschwil
The company is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules.
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