Alpine Cluster QA Lead - Switzerland and Austria

Welcome to AbbVie!We are a global, research-based biopharmaceutical company focused on the discovery and development of innovative treatments that address some of the world’s most serious and complex diseases. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology. In addition, AbbVie offers products and services through its Allergan Aesthetics portfolio.

AbbVie with headquarters in Chicago, USA, employs approximately 50,000 employees worldwide and is celebrating its 10th anniversary in 2023. Around 57 million patients in more than 175 countries benefit from AbbVie medications annually. Approximately 250 employees are employed in Switzerland and the AbbVie Switzerland headquarters are located in Cham, ZG. For more information, visit our website: www.abbvie.ch

As part of an international company, you will have the opportunity to work closely with us to address the health challenges of tomorrow.

Make an impact:

With a lot of experience and even more passion, you will lead the Alpine Cluster Commercial Quality Team based in Switzerland and Austria affiliates.

Furthermore, as FvP, you will ensure that all business is conducted in compliance with the Swiss law on Medicinal Products as well as with AbbVie company policies.

You will also be responsible by law for direct technical supervision of the operation, safety, efficacy, and quality of the medicine, and ensures the proper handling of pharmaceutical products, importing and wholesaling in accordance with the rules of Good Distribution Practice (GDP) and Swiss CC 812.21 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA)

KEY RESPONSIBILITIES AS ALPINE CLUSTER , COMMERCIAL QUALITY ASSURANCE:

• Responsible for the integration and support of quality regulations: drug, biologics, device and/or combination products driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.

• Responsible for the management and oversight teams across multiple affiliates within a region including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues. Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs.

• Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.

• Lead and oversee support activities related to product actions in the affiliate.

• Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity.

• Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward.

• Responsible for partnering and overseeing support activities related to product actions in the

• Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.

• Quality management of supplier qualification program including performance monitoring for key suppliers, QTA management and assessments.

• Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.

• Represent affiliate QA in regional, global and cross functional teams, projects and programs, as appropriate.

FUTHER RESPONSIBILITIES AS FVP:

• Act as FvP for the Import and Wholesaling in accordance with the Swiss law on Medicinal Products (Heilmittelgesetz, HMG; Arzneimittel-Bewilligungsverordnung, AMBV) and Swissmedic technical interpretation I-SMI.TI.17 Responsible Person: requirements. The FvP has the authority to issue directives within the sphere of her/his responsibilities.

• Supervision of the business and ensure the appropriate handling of medicines and wholesaling activities.

• Apply and keep current the necessary license(s) for the business of the affiliate.

• 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 according to the approved specifications and in accordance with the rules of Good Distribution Practice (GDP).

• Ensure that manufacturers of imported pharmaceutical products 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 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 salable 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 all products marketed in Switzerland.

• Management of Health Authority Inspections and Corporate Audits.

• Management of recalls.

• Management of product quality complaints (receipt, classification, forwarding to the manufacturer, tracking, information to customers, reconciliation).

• Report quality issues to Swissmedic according to requirements and within deadlines.

• Handle quality issues with the responsible Warehouse/Supplier/Manufacturing Site.

• Remain up-to-date with Swiss regulatory requirements, authority organization, processes and environment

• Awareness and implementation of applicable regulations and dissemination to relevant internal and external stakeholders.

• Act as contact person for all Quality issues for AbbVie AG for Swissmedic, the Cantonal Health Authority, RFS and Third-Party Manufactures.

• Planning and performing of internal audits.

• Ensure that Site Quality Compliance Metrics are reported periodically to the Site Management.

• Lead of Management Reviews.

• Ensure that employees involved in distribution activities perform a GDP refresher training at the minimum with a yearly frequency.