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Enterprise Quality Auditing Auditor (Senior Manager)(m/w/x)
Leading GxP quality audits for biopharmaceutical products at a global biopharma. Six years pharmaceutical quality experience and 50% international travel required. Focus on life-improving medicines for complex diseases.
Anforderungen
- Willingness for 50% international travel
- Scientific degree or equivalent qualification
- Six years' experience in pharmaceutical quality
- Four years leading quality audits
- Knowledge of pharmaceutical quality systems
- Understanding of local and global regulations
- Ability to analyze complex processes
- Strong problem-solving and risk management
- Experience in GxP or QMS
- Competence in leading single-discipline audits
- Experience working in international teams
- Fluent written and spoken English
- Proficiency with current digital tools
Aufgaben
- Lead the planning and execution of GxP quality audits
- Perform risk-based audit preparation and data mining
- Develop audit agendas and document performance observations
- Monitor and improve PV and Medical system audit metrics
- Assess risks and evaluate corrective action responses
- Approve audit reports and official records
- Manage self-inspections and resolve resulting CAPAs
- Support inspection readiness and due diligence activities
- Collaborate with R&D and Pharmacovigilance on supplier audits
- Drive continuous improvement for quality auditing processes
- Participate in Communities of Practice and risk assessments
- Train lead auditors on procedures and policies
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Quality Management Systems (QMS)
- Digital tools
Benefits
Abwechslungsreiche Aufgaben
- Stimulating careers
Lockere Unternehmenskultur
- Inclusive, collaborative workplace
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Enterprise Quality Auditing Auditor (Senior Manager)(m/w/x)
Leading GxP quality audits for biopharmaceutical products at a global biopharma. Six years pharmaceutical quality experience and 50% international travel required. Focus on life-improving medicines for complex diseases.
Anforderungen
- Willingness for 50% international travel
- Scientific degree or equivalent qualification
- Six years' experience in pharmaceutical quality
- Four years leading quality audits
- Knowledge of pharmaceutical quality systems
- Understanding of local and global regulations
- Ability to analyze complex processes
- Strong problem-solving and risk management
- Experience in GxP or QMS
- Competence in leading single-discipline audits
- Experience working in international teams
- Fluent written and spoken English
- Proficiency with current digital tools
Aufgaben
- Lead the planning and execution of GxP quality audits
- Perform risk-based audit preparation and data mining
- Develop audit agendas and document performance observations
- Monitor and improve PV and Medical system audit metrics
- Assess risks and evaluate corrective action responses
- Approve audit reports and official records
- Manage self-inspections and resolve resulting CAPAs
- Support inspection readiness and due diligence activities
- Collaborate with R&D and Pharmacovigilance on supplier audits
- Drive continuous improvement for quality auditing processes
- Participate in Communities of Practice and risk assessments
- Train lead auditors on procedures and policies
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Quality Management Systems (QMS)
- Digital tools
Benefits
Abwechslungsreiche Aufgaben
- Stimulating careers
Lockere Unternehmenskultur
- Inclusive, collaborative workplace
Über das Unternehmen
Takeda Manufacturing Austria AG
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein weltweit führendes, forschendes biopharmazeutisches Unternehmen, das lebensverbessernde Arzneimittel für komplexe Erkrankungen entwickelt.
Noch nicht perfekt?
- 3123 Intervet GmbH Austria
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VollzeitBefristeter Vertragnur vor OrtSeniorWienab 61.300 / Jahr - mySugr GmbH
Engineering Manager Quality Assurance(m/w/x)
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Engineering Manager Quality Assurance(m/w/x)
Vollzeitnur vor OrtSeniorWienab 80.000 / Jahr - Octapharma
Deputy Head QC Projects(m/w/x)
VollzeitBefristeter Vertragnur vor OrtBerufserfahrenWienab 4.686,11 / Monat - mySugr GmbH
Scrum Master(m/w/x)
Vollzeitnur vor OrtManagementWienab 3.843 / Monat