QA Manager (FvP/Responsible Person)

• 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.
• Accountable for the integration and support of quality regulations at the affiliate: drug, biologics, device and/or combination and cosmetics 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.
• Accountable for the management and oversight of an affiliate team, as applicable, 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.
• 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 all products marketed in Switzerland.
• Management of recalls.
• Oversight 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.
• Ensure that employees involved in distribution activities perform a GDP refresher training at the minimum with a yearly frequency.
• Participate in a course, seminar, congress or equivalent with focus on GMP/GDP at the minimum once a year to stay up to date with the current regulatory requirements and industry standards.
• Assess education and experience of the Deputy FvP and assign delegation.

• Degree in Chemistry, Pharmacy, Biology, other technical/scientific area, MBA or M.S. preferred.
• Minimum 5 years' experience in quality assurance, operations or other relevant areas, with proven prior experience in Good Distribution Practice (GDP). Management experience preferred.
• Full understanding of local GxP requirements with an in-depth knowledge of some elements.
• General knowledge and understanding of AbbVie MD, pharmaceutical, biologic and cosmetic products and regulations, how supplied, therapeutic uses/indications, strategic importance for the business and knowing how to get this information
• Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations.
• As holder of the responsibility of the FvP, you must have the necessary professional training and experience to be accepted by the authorities for this function
• Ability to coach and develop others. Invests in people, amplifies strengths to build the best talent
• Makes decisions with minimal direction (within scope of role)
• Excellence focused - Drives results by focusing on prioritization and continuous improvement
• Influencing. Understand your stakeholders and shape communication; can negotiate to win
• Leading with presence - Motivate their team, build relationships and inspire followership
• Business Acumen - Knowing how QA connects to the broader business objectives - We need to have an organization, culture and team members that will push the envelope - leaders that are embracing, promoting and driving change
• Familiar with SAP, TrackWise, ComplianceWire, OneVault
• Excellent written and oral communication skills.
• Proficiency in English and German

AbbVie