Quality Audit Management Lead

vor 2 Wochen

St Gallen, Schweiz Vifor Pharma Vollzeit

-We are currently looking for a Quality Audit Management Lead to join our team in St. Gallen. In this position you will have overall responsibility & accountability for the oversight and management of CSL Vifor GxP Quality Assurance audit programs including GMP, GDP, and Clinical, Medical, Regulatory & Safety (CMRS) aspects in line with existing regulations. You will be accountable for the inspection management and the management of the supplier qualification process including audit planning, conducting and reporting of annual performance review of third-party services. You will be directly reporting to the Head of Quality Assurance & CMRS and will be responsible for leading a small team.

**Key Tasks**
- Oversight of GXP audit planning and execution
- Lead Auditor for GMP-/ GDP external / internal audits
- Management of self-inspection lead auditor group
- Host of GMP- HA/RA and customer inspection/audits
- Reflect regulatory standards on audit management process and third party management process
- Ensure completion of all required third party vendor qualification processes and performance reviews
- Confirmation of management and closure of audit related CAPAs according to global/local standards
- Management and assessment of third party audit vendors and consultants
- Ensure that all audit records are updated and maintained in Trackwise, including related CAPA

**Qualifications**

**Minimum Requirements**
- Minimum of 8 years overall experience within the pharmaceutical, biotechnology industry or CMO
- Preferably 5 years‘ experience in a Quality Assurance role, ideally with supervisory/management experience including global and/or regional audit responsibility
- Proven track record in managing external service providers (CMO)
- Fluency in English and good level of German
- Excellent Communication Skills

**Preferred Requirements**
- Degree/masters in Natural Sciences
- Lean six sigma/Operational excellence qualification/experience
- Experience of managing/interacting with global stakeholders

**About Us**:

  • Quality Audit Management Lead

    vor 2 Wochen

    St. Gallen, Schweiz CSL Behring Vollzeit

    We are currently looking for a Quality Audit Management Lead to join our team in St. Gallen. In this position you will have overall responsibility & accountability for the oversight and management of CSL Vifor GxP Quality Assurance audit programs including GMP, GDP, and Clinical, Medical, Regulatory & Safety (CMRS) aspects in line with existing regulations....

  • Quality Audit

    vor 1 Woche

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Quality Audit & Supplier Qualification, St. GallenClient:CSLLocation:St. GallenJob Category:OtherJob Reference:f2c9b3c98fc3Job Views:11Posted:22.01.2025Expiry Date:08.03.2025Job Description:Title: Auditor (Senior), External Supplier QualityType of role: Permanent positionWe are looking for a (Senior) Auditor...

  • Lead Auditor

    Vor 6 Tagen

    St. Gallen, Schweiz CSL Vifor Vollzeit

    We are looking for a (Senior) Lead Auditor, External Supplier Quality to join our Quality team in St. Gallen on a permanent basis. You will support the local site regarding supplier/third-party qualification status and process and will report directly to the Head of Supplier Quality Management (CH). We are offering a flexible and hybrid working model.Main...

  • Lead Auditor

    vor 1 Woche

    St. Gallen, Schweiz CSL Behring Vollzeit

    For our location in St.Gallen, we are currently looking for a **LEAD AUDITOR**: **RESPONSIBILITIES**: - organize and perform GMP-/ GDP external / internal audits and self-inspection as lead auditor - reflect regulatory standards on audit management process and thirdparty management process - perform third party vendor qualification processes and...

  • Lead Auditor

    vor 1 Woche

    Sankt Gallen, Schweiz CSL Plasma Inc. Vollzeit

    Lead Auditor (Senior), External Supplier QualityLead Auditor (Senior), External Supplier QualityWe are looking for a (Senior) Lead Auditor, External Supplier Quality to join our Quality team in St. Gallen on a permanent basis. You will support the local site regarding supplier/third-party qualification status and process and will report directly to the Head...

  • Supplier Development

    Vor 3 Tagen

    St. Gallen, Schweiz CORNFELD Executive Search, Zurich Vollzeit

    A leading Swiss industrial group is seeking exclusively through us the contact with a Supplier Development & Quality Manager. We are looking for an international Supply Chain leader who is comfortable working and communicating in a global, ambiguous and cyclical demand environment. You will be responsible for executing and driving supplier development and...

  • Quality Assurance Manager/ Supplier Management Oral

    vor 2 Wochen

    St. Gallen, Schweiz CSL Behring Vollzeit

    We are currently looking for a Quality Assurance Manager /Specialist CMO/ Supplier Management Oral Products to join our team in St Gallen. **Main Responsibilities** - Management of CMOs and Suppliers for the oral portfolio. - Processing all quality related tasks for the outsourced manufacturing and services to different contract manufacturing organizations...

  • Quality Assurance Manager/ Supplier Management Oral

    vor 2 Wochen

    St. Gallen, Schweiz Vifor Pharma Vollzeit

    -CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead...

  • Head of Global Quality Management

    vor 2 Wochen

    St. Gallen, Schweiz LHH Vollzeit

    Werden Sie Teil des hoch angesehenen Teams unseres Kunden als** Head of Global Quality Management (w/m/d)** und präsentieren Sie Ihre Expertise in Standardisierung, internen Audits, Zertifizierungen, Implementierung von Qualitätsmanagementsystemen und Top-Management-Workshops. Diese außergewöhnliche Gelegenheit ermöglicht es Ihnen, in einem dynamischen...

  • Quality Operations Manufacturing Science Qc

    vor 1 Woche

    St. Gallen, Schweiz CSL Behring Vollzeit

    At CSL Vifor we have established a new organizational model for managing important Contract Manufacturing Organization (CMO) partnerships. In this context, we are offering an exciting opportunity for our Quality Operations External API & Oral Products Department as **Quality Operations Manufacturing Science QC Support** Manager**: In this role you will...

  • Quality Engineer

    vor 1 Woche

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    In this role, you will have the opportunity to drive meaningful improvements, collaborate with talented professionals, and contribute to the ongoing success of a global leader in data and energy transmission technologies.Candidate profile:Technical Expertise: In-depth understanding of high-frequency, fiber optic, and low-frequency technologies, including the...

  • GMP Quality Assurance Professional

    Vor 7 Tagen

    St. Gallen, Sankt Gallen, Schweiz CSL Vifor Vollzeit

    About the RoleWe are looking for a talented professional to join our team as a QA Compliance and System Specialist. In this role, you will play a critical part in ensuring compliance with company standards and regulatory guidelines, developing and maintaining GMP-related standard operating procedures (SOPs), and supporting various quality processes.Your...

  • Sachbearbeiterin Gxp Quality Systems

    vor 2 Wochen

    St. Gallen, Schweiz CSL Behring Vollzeit

    Zur Verstärkung unseres Qualitätsteams in St. Gallen suchen wir derzeit eine(n) SachbearbeiterIn GxP Quality Systems für einen befristeten Vertrag (12 Monate). In dieser Position berichten Sie direkt an den Leiter des Qualitätsmanagementsystems. Wir bieten ein flexibles und hybrides Arbeitsmodell an. (#LI-Hybrid) **Hauptaufgaben** - Administrative...

  • Product Quality Manager in

    vor 1 Woche

    St. Gallen, Schweiz Online Doctor AG Vollzeit

    **About OnlineDoctor**: OnlineDoctor is at the forefront of digital healthcare, providing a platform where patients can easily and safely interact with doctors online. We handle sensitive information daily and are committed to maintaining the highest standards of quality, safety, and compliance in our products. Quality assurance at OnlineDoctor is deeply...

  • Head of Quality

    vor 1 Woche

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Responsibilities:Management and further development of all areas of quality management with a total of 8 employeesFurther development of the existing quality, safety and environmental management systems in collaboration with managementSupport of internal areas such as operations, research & development and sales...

  • Global Supplier Development

    vor 2 Wochen

    St. Gallen, Schweiz CORNFELD Executive Search, Zurich Vollzeit

    Ein führender Schweizer Industriekonzern sucht exklusiv über uns den Global Supplier Development & Quality Manager. Wir suchen eine internationalen Supply Chain Leader-Persönlichkeit, die sich in einem anspruchsvollen, hoch dynamischen und zyklischen Nachfrageumfeld weiter entwickeln will. Aufgaben Als Global Supplier Quality & Development Manager sind...

  • Quality Manager Distribution

    vor 1 Woche

    Sankt Gallen, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:With a diverse portfolio of more than 20 brands sold in approximately 150 countries and territories, Estée Lauder Companies is the global leader in prestige beauty, recognized for its skincare, make-up, fragrances, and hair care products.In Switzerland, Estée Lauder has the main Supply Chain Hub for Travel Retail...

  • Npi QA Manager

    vor 2 Wochen

    St. Gallen, Schweiz Vifor Pharma Vollzeit

    -CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead...

  • Project Quality Manager

    vor 2 Wochen

    St. Gallen, Schweiz Onyx Circle AG Vollzeit

    Über unseren Kunden Unser Kunde mit Sitz im Kanton St. Gallen ist in der Entwicklung und Herstellung innovativer sowie hochwertiger Elektronikkomponenten tätig, welche in Elektroautos zum Einsatz kommen. Mit Sitz in der Schweiz investiert die Firma stetig in den hiesigen Standort und ist aktuell dabei, das bestehende Team stark auszubauen. Aus diesem...

  • QA Manufacturing Science Manager

    vor 1 Woche

    St. Gallen, Schweiz Vifor Pharma Vollzeit

    CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better,...