QA Manager Systeme

Experis is a leading specialist in IT staffing solutions. With offices in Zurich, Basel, Geneva, Bern, and Lugano, we focus on IT recruitment and support our clients in filling key roles in the technology and IT sector.

Contract Lenght: 01.03.2025 - 28.02.2027

Location: Stein, Aargau

Key Responsibilities:

• Ensure the effective implementation, compliance, and reporting of Quality Management Systems across the Sisseln site.
• Define and maintain the site's cGMP status in alignment with regulatory guidelines (e.g., ICH, ISO) and legal requirements (e.g., pharmacopoeias, CEP, FSSC, FAMI-QS), ensuring all local documents remain compliant and up to date.
• Review, approve, and release quality-related documents, including specifications, manufacturing instructions, and validation records.
• Lead continuous improvement initiatives for the Quality Management System using Lean principles to enhance efficiency and effectiveness.
• Develop and execute strategic quality concepts to address evolving regulatory requirements and customer expectations while proactively monitoring industry changes.
• Conduct and oversee Product Quality Reviews (PQRs) and Annual Product Reviews (APRs) for assigned products and services (e.g., water systems).
• Play an active role in quality processes, including managing deviations, complaints, and change controls while ensuring informed decision-making.
• Collaborate closely with supply chain functions to address quality-related concerns and drive process improvements.
• Support business partners in optimizing product attributes and enhancements, particularly during growth phases.
• Manage internal audit processes, host external inspections (regulatory bodies, customers, suppliers), and ensure audit readiness and timely resolution of findings.
• Make empowered quality-related decisions, ensuring adherence to regulatory requirements and internal quality standards.
• Escalate critical quality issues to the responsible Qualified Person (QP/FvP) and Head of Quality.
• Ensure accuracy, consistency, and timely availability of quality-related documentation and performance metrics.
• Authorize, approve, or reject quality documents, including reports, SOPs, and guidelines.
• Represent the organization in global quality networks and communities of practice.
• Lead by example in fostering a culture of quality excellence and compliance.

Projects & Special Initiatives:

• Drive continuous improvement projects to enhance the efficiency of the Quality Management System.
• Supervise project execution, ensuring compliance with Kosher/Halal requirements, data integrity, and computerized system validation (CSV).
• Oversee analytical laboratory activities from a Quality Assurance perspective and ensure harmonization of non-product-specific GMP requirements.
• Qualify and certify suppliers in line with regulatory and quality expectations.
• Deliver quality-related training programs to enhance awareness and compliance across teams.
• Lead Six Sigma projects and complex investigations to resolve critical quality challenges.
• Implement new regulatory trends within the site's Quality Management System to maintain industry compliance and best practices.
• Review corporate directives and best practices, ensuring their seamless integration into local procedures.

Our client offers you the opportunity to work in a dynamic and future-oriented environment while continuously developing your skills. Does this sound like you, and do you meet the required qualifications? Then we look forward to receiving your application!