We are currently seeking a
QA Compliance Manager
to join our QA Compliance team in
St. Gallen, Switzerland . This position reports directly to the Head of QA Site Compliance.
Responsibilities
Own the CSL Vifor Quality Management System (QMS) Framework, ensuring its continuous development, implementation, maintenance, and compliance with corporate quality standards, regulatory requirements, and applicable GxP guidelines.
Serve as the QA Manager and Single Point of Contact (SPOC) for the enterprise-wide Document and Training Management processes across CSL Vifor.
Drive and lead QMS harmonization initiatives to standardize and continuously improve quality processes and systems across the organization.
Independently manage QMS-related projects, coordinating cross-functional stakeholders, monitoring progress, and ensuring successful implementation.
Provide end‑to‑end ownership of key Quality and Compliance processes, acting as the primary subject matter expert and business partner for stakeholders across CSL Vifor.
Qualifications
Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, or another relevant scientific discipline.
At least 5 years of experience in Quality Assurance, Quality Management Systems (QMS), and/or Compliance Management, ideally within a GMP‑regulated pharmaceutical or biotechnology environment.
Strong knowledge of Quality Management Systems, cGMP principles, and regulatory compliance requirements.
Proven stakeholder management skills with the ability to influence, align, and collaborate across functions within a global matrix organization.
Strong analytical, organizational, and problem‑solving skills with a structured and solution‑oriented approach.
Fluent English required; German language skills are an advantage.
Benefits For more information on CSL benefits visit How CSL Supports Your Well‑being | CSL.
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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QA Compliance Manager
to join our QA Compliance team in
St. Gallen, Switzerland . This position reports directly to the Head of QA Site Compliance.
Responsibilities
Own the CSL Vifor Quality Management System (QMS) Framework, ensuring its continuous development, implementation, maintenance, and compliance with corporate quality standards, regulatory requirements, and applicable GxP guidelines.
Serve as the QA Manager and Single Point of Contact (SPOC) for the enterprise-wide Document and Training Management processes across CSL Vifor.
Drive and lead QMS harmonization initiatives to standardize and continuously improve quality processes and systems across the organization.
Independently manage QMS-related projects, coordinating cross-functional stakeholders, monitoring progress, and ensuring successful implementation.
Provide end‑to‑end ownership of key Quality and Compliance processes, acting as the primary subject matter expert and business partner for stakeholders across CSL Vifor.
Qualifications
Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, or another relevant scientific discipline.
At least 5 years of experience in Quality Assurance, Quality Management Systems (QMS), and/or Compliance Management, ideally within a GMP‑regulated pharmaceutical or biotechnology environment.
Strong knowledge of Quality Management Systems, cGMP principles, and regulatory compliance requirements.
Proven stakeholder management skills with the ability to influence, align, and collaborate across functions within a global matrix organization.
Strong analytical, organizational, and problem‑solving skills with a structured and solution‑oriented approach.
Fluent English required; German language skills are an advantage.
Benefits For more information on CSL benefits visit How CSL Supports Your Well‑being | CSL.
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
#J-18808-Ljbffr
QA Compliance Manager Arbeitgeber: CSL
CSL ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern ein dynamisches und unterstützendes Arbeitsumfeld bietet. Mit einem starken Fokus auf persönliche Entwicklung und Weiterbildungsmöglichkeiten, insbesondere im Bereich Veranstaltungen und Transparenzmanagement, fördert das Unternehmen eine Kultur der Zusammenarbeit und Innovation. Die Lage ermöglicht es den Mitarbeitern, in einem inspirierenden Umfeld zu arbeiten, während sie gleichzeitig von attraktiven Benefits und einer ausgewogenen Work-Life-Balance profitieren.
