QA Analytics Manager – GxP & QC Compliance

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career and dynamic culture

Inclusive workplace

Competitive compensation

Role/location dependent benefits

Zusammenfassung

Lonza in Visp, Switzerland, seeks a QA Manager (f/m/d) for QA Analytics to ensure QC processes comply with GxP, data integrity and regulatory standards. You will interface between QC and QA Operations, interacting with senior site stakeholders to drive CAPA and investigations to completion.

You will support cross-functional teams, review critical documents, and lead QA Analytics initiatives, including regulatory inspections support and SOP revisions, while aligning with Lonza’s values and

Qualifikationen

• Academic degree in Chemistry/Biochemistry/Biotechnology/ Life Science or related field.
• Profound working experience in the pharmaceutical industry within QC/QA required.
• Experience with analytical method validation, change management, deviation management and OOX investigations.
• Strong background in cGMP regulations, incl. USP, European and Japanese Pharmacopeia.
• Auditing experience and interaction with Health Authorities (FDA, Swissmedic).
• Experience in cross-functional teams and collaboration with stakeholders.
• Excellent verbal and written communication in English; German is advantageous.

Aufgaben

• Represent QA Analytics in cross-functional teams and meetings.
• Represent QA concerns to QC and ensure GxP requirements and SOPs are followed.
• Review and approve QC/AD related documents (e.g., method transfer and validation documents, SOPs).
• Review and approve TW records related to QC processes.
• Ensure QC deviations/investigations are properly investigated and documented per regulatory requirements.
• Act as decision-maker during QC deviations/investigation process.
• Drive QA Analytics and QC CAPA and Effectiveness checks to timely closure.
• Ensure documents are correct and adhere to SOPs and customer requirements.
• Provide SME guidance in QA Analytics and support SOP updates and regulatory inspections.

Kenntnisse

Cross-functional teamwork

Auditing experience

Regulatory interaction

Analytical method validation

Quality systems

Ausbildung

Chemistry/Life Sciences degree

Jobbeschreibung

Lonza in Visp, Switzerland, seeks a QA Manager (f/m/d) for QA Analytics to ensure QC processes comply with GxP, data integrity and regulatory standards. You will interface between QC and QA Operations, interacting with senior site stakeholders to drive CAPA and investigations to completion.

You will support cross-functional teams, review critical documents, and lead QA Analytics initiatives, including regulatory inspections support and SOP revisions, while aligning with Lonza’s values and