QA Manager (FvP/Responsible Person)

Responsibilities

• Assure key affiliate metrics are being monitored (goals, CAPA, change plans etc.) Use data and facts to make decisions and to pursue compliance/continuous improvement opportunities. Conduct management reviews as per plan.
• Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward.
• Host internal, external and MoH audits. Confidently knowing and understanding the affiliate business, licenses, distribution nodes, quality system applicability to support successful audits.
• Accountable for supplier qualification program including performance monitoring for key suppliers, QTA management and assessments.
• Accountable for all activities governed by Good Storage and Distribution Practices at the affiliate, including monitoring of controlled temperature and cold chain shipments.
• Represent affiliate QA or act as a lead in regional, global and cross functional teams, projects and programs, as appropriate.
• Ensure that a Quality Management System is available, implemented and maintained for the provision of work instructions, procedures and protocols for GMP and GDP-related processes.
• Ensure that the medicinal products are supplied and distributed into Switzerland according to the approved specifications and in accordance with the rules of Good Distribution Practice (GDP).
• Ensure that manufacturers of imported pharmaceutical products into Switzerland hold a valid GMP manufacturing license.
• Ensure the traceability of purchases and sales of pharmaceutical products and recording the necessary information concerning this.
• Ensure that the pharmaceutical products released onto the Swiss market meet the specifications in force and are manufactured in accordance with Good Manufacturing Practice (GMP).
• Release of commercial products for the Swiss market independent from management and commercial functions (primarily based on the release documents of the QP of the manufacturer / batch releasing site).
• Independently from management, decide whether a batch can be released for distribution to market and command stop of distribution and recall of batches if needed.
• Management of quality and compliance risks.
• Approval of all SOPs and other controlled documents in conjunction with the GMP/GDP batch release to the Swiss Market.
• Authorize the return to saleable stock or destruction of any returned medicines.
• Contact person for and approval of Technical/Quality Agreements related to the supply, transportation and wholesale of medicinal products marketed by AbbVie AG.
• Quality oversight /auditing of external service providers (e.g., external warehouse).
• Perform PQR review for al

Benefits

Additional Information

Job summary: The AbbVie AG Responsible person (FvP) is responsible for providing leadership and oversight of Quality Compliance matters across the commercial entity within the affiliate in support of the quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics and cosmetics. Specific areas include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. By law, the Responsible person is directly accountable for the technical supervision of operations, guaranteeing the safety, efficacy, and quality of medicines. The FvP ensure proper handling of pharmaceutical products, as well as activities related to importing and wholesaling, all in strict compliance with Swiss law on Medicinal Products, AbbVie company policies, and the principles of Good Distribution Practice (GDP). We're looking for a curious and driven individual to take on this role of critical importance, with the opportunity for future growth. Your development is not limited to this role but has open paths available both with AbbVie in Switzerland and internationally.

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