job details

For our client based in Basel and specialized in pharma area, we're looking for a QA Manager - Responsable Person


Responsibilities

• Support Quality activities in LATAM and MMG operational areas, acting as the Responsible Person for LATAM GmbH and Medical GmbH.
• Execute Quality Management system activities on behalf of IACs to ensure compliance with GxP legislation.
• Provide oversight of Quality Assurance activities for third-party manufacturers, packaging operations, and other outsourced entities in Consumer Health and Ethical areas.
• Conduct Supplier Assurance activities to maintain the qualification status of raw material and packaging suppliers.
• Offer Quality advice and support to internal and external stakeholders.
• Implement and maintain a Quality Management System, complying with relevant regulations.
• Act as the Responsible Person for LATAM GmbH and Medical GmbH, and as Deputy Responsible Person for MLG, MAG, MNE MEA, and MMCO.

Additional Responsibilities:

• Lead Basel Quality Management System activities, including Complaints, Change Control, Recall, Audits, Self-Inspections, and Training.
• Lead Supplier, Customer, and Service provider qualification activities, including audits.
• Implement and update Technical Quality Agreements with Suppliers and Customers. Support and lead Quality Management Reviews and regular reports to upper Management.
• Assist Independent Associated Companies with Quality-related topics.
• Escalate significant Quality issues to superiors.
• Serve as a local expert for GxP-related questions.
• Manage Third-Party providers by updating agreements, conducting Quality Review Meetings, ensuring regulatory documentation, and reviewing stability data.
• Review third-party Change Control, Deviations, CAPA, and Complaints using risk management principles.
• Participate collaboratively with internal and external stakeholders to resolve issues and ensure product quality, compliance, and supply.
• Establish effective partnerships and relationships with third parties.

Profile 

• Degree in natural science (Chemistry, Pharmacy, Biology, etc.) or higher.
• Minimum 5 years of QA experience, preferably in a managerial role in the pharmaceutical industry.
• Experience in Quality Supplier Management.
• Excellent knowledge of GMP and GDP regulations for drugs, devices, cosmetics, etc.
• Fluent in spoken and written English; German language skills is a plus.

For our client based in Basel and specialized in pharma area, we're looking for a QA Manager - Responsable Person


Responsibilities

• Support Quality activities in LATAM and MMG operational areas, acting as the Responsible Person for LATAM GmbH and Medical GmbH.
• Execute Quality Management system activities on behalf of IACs to ensure compliance with GxP legislation.
• Provide oversight of Quality Assurance activities for third-party manufacturers, packaging operations, and other outsourced entities in Consumer Health and Ethical areas.
• Conduct Supplier Assurance activities to maintain the qualification status of raw material and packaging suppliers.
• Offer Quality advice and support to internal and external stakeholders.
• Implement and maintain a Quality Management System, complying with relevant regulations.
• Act as the Responsible Person for LATAM GmbH and Medical GmbH, and as Deputy Responsible Person for MLG, MAG, MNE MEA, and MMCO.

Additional Responsibilities:

• Lead Basel Quality Management System activities, including Complaints, Change Control, Recall, Audits, Self-Inspections, and Training.
• Lead Supplier, Customer, and Service provider qualification activities, including audits.
• Implement and update Technical Quality Agreements with Suppliers and Customers. Support and lead Quality Management Reviews and regular reports to upper Management.
• Assist Independent Associated Companies with Quality-related topics.
• Escalate significant Quality issues to superiors.
• Serve as a local expert for GxP-related questions.
• Manage Third-Party providers by updating agreements, conducting Quality Review Meetings, ensuring regulatory documentation, and reviewing stability data.
• Review third-party Change Control, Deviations, CAPA, and Complaints using risk management principles.
• Participate collaboratively with internal and external stakeholders to resolve issues and ensure product quality, compliance, and supply.
• Establish effective partnerships and relationships with third parties.

Profile 

• Degree in natural science (Chemistry, Pharmacy, Biology, etc.) or higher.
• Minimum 5 years of QA experience, preferably in a managerial role in the pharmaceutical industry.
• Experience in Quality Supplier Management.
• Excellent knowledge of GMP and GDP regulations for drugs, devices, cosmetics, etc.
• Fluent in spoken and written English; German language skills is a plus.