Dein persönlicher KI-Karriere-Agent
QA Project Manager - Drug Product(m/w/x)
Establishing Quality Agreements for manufacturing, representing the quality function in project teams and customer technical transfers. Long-term GMP pharmaceutical industry experience required. Customer-facing role with technical transfer focus.
Anforderungen
- University degree or equivalent in Chemistry, Biology, Biotechnology, or related field
- Long-term experience in GMP pharmaceutical industry environment
- Advantageous: QA department experience
- Business fluent English
- Advantageous: German language skills
Aufgaben
- Establish Quality Agreements (QAA) with DPS and LONZA DS sites.
- Represent QA in project teams.
- Represent QA in customer meetings during technical transfer.
- Serve as QA contact for specific projects.
- Manage customer interface for DRs and CRs.
- Serve as point of contact for customer QA inquiries and complaints.
- Organize customer audits with compliance and DPS teams.
- Support and approve project and regulatory risk assessments.
- Review and release product documentation (e.g., protocols, test plans).
- Collaborate with QC-PL and MSAT for New Product Introductions (NPIs).
- Support inspection organization (front and back office).
- Represent Drug Product QA during regulatory inspections.
- Support continuous improvement for Visp DPS Quality Management System (QMS).
- Represent QA in cross-functional teams.
- Establish and maintain interfaces with manufacturing, QC, and engineering.
- Facilitate technology transfer for drug products.
- Assess, review, and approve quality records and release dossiers.
- Manage deviations, change controls, and CAPAs.
- Conduct investigations and effectiveness checks.
- Handle complaints and APR/PQRs.
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic working culture
- Inclusive workplace
Sinnstiftende Arbeit
- Ethical workplace
Attraktive Vergütung
- High-performance compensation programs
Sonstige Vorteile
- Relocation assistance
Noch nicht perfekt?
- LonzaVollzeitnur vor OrtSeniorVisp
- CH12 Lonza AG
Senior QA Specialist, QA Project Management(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist/QA Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
(Senior) QA Qualification Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVisp - Lonza
Associate Director, QA SAP Project Management(m/w/x)
Vollzeitnur vor OrtSeniorVisp
QA Project Manager - Drug Product(m/w/x)
Establishing Quality Agreements for manufacturing, representing the quality function in project teams and customer technical transfers. Long-term GMP pharmaceutical industry experience required. Customer-facing role with technical transfer focus.
Anforderungen
- University degree or equivalent in Chemistry, Biology, Biotechnology, or related field
- Long-term experience in GMP pharmaceutical industry environment
- Advantageous: QA department experience
- Business fluent English
- Advantageous: German language skills
Aufgaben
- Establish Quality Agreements (QAA) with DPS and LONZA DS sites.
- Represent QA in project teams.
- Represent QA in customer meetings during technical transfer.
- Serve as QA contact for specific projects.
- Manage customer interface for DRs and CRs.
- Serve as point of contact for customer QA inquiries and complaints.
- Organize customer audits with compliance and DPS teams.
- Support and approve project and regulatory risk assessments.
- Review and release product documentation (e.g., protocols, test plans).
- Collaborate with QC-PL and MSAT for New Product Introductions (NPIs).
- Support inspection organization (front and back office).
- Represent Drug Product QA during regulatory inspections.
- Support continuous improvement for Visp DPS Quality Management System (QMS).
- Represent QA in cross-functional teams.
- Establish and maintain interfaces with manufacturing, QC, and engineering.
- Facilitate technology transfer for drug products.
- Assess, review, and approve quality records and release dossiers.
- Manage deviations, change controls, and CAPAs.
- Conduct investigations and effectiveness checks.
- Handle complaints and APR/PQRs.
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic working culture
- Inclusive workplace
Sinnstiftende Arbeit
- Ethical workplace
Attraktive Vergütung
- High-performance compensation programs
Sonstige Vorteile
- Relocation assistance
Über das Unternehmen
Lonza
Branche
Pharmaceuticals
Beschreibung
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Noch nicht perfekt?
- Lonza
Senior QA Specialist, DPS (Drug Product Services)(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Senior QA Specialist, QA Project Management(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist/QA Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
(Senior) QA Qualification Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVisp - Lonza
Associate Director, QA SAP Project Management(m/w/x)
Vollzeitnur vor OrtSeniorVisp