Job Description
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 ensures 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.
Key Responsibilities
* Act as FvP for Import and Wholesaling in accordance with Swiss law on Medicinal Products (HMG; AMBV) and Swissmedic technical interpretation I-SMI.TI.17 Responsible Person.
* 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.
* Accountable for the management and oversight of an affiliate team, including hiring, setting performance expectations, providing performance feedback, staff development, and handling personnel issues.
* Ensure key affiliate metrics are monitored (goals, CAPA, change plans) and use data to drive compliance and continuous improvement.
* Partner with stakeholders across the enterprise to align on processes external to QA.
* Host internal, external and MoH audits, supporting the affiliate’s business, licenses and quality system applicability.
* 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, monitoring controlled temperature and cold chain shipments.
* Represent affiliate QA or act as a lead in regional, global and cross‑functional teams, projects and programs.
* Ensure that a Quality Management System is implemented and maintained with work instructions, procedures and protocols for GMP and GDP‑related processes.
* Ensure medicinal products are supplied and distributed into Switzerland according to approved specifications and GDP rules.
* Ensure that manufacturers of imported pharmaceutical products hold a valid GMP manufacturing license.
* Ensure traceability of purchases and sales of pharmaceutical products and record necessary information.
* Ensure products released onto the Swiss market meet specifications and are manufactured per GMP.
* Independently decide whether a batch can be released for distribution or command stop of distribution and recall of batches if needed.
* Manage quality and compliance risks.
* Approve all SOPs and other controlled documents in conjunction with GMP/GDP batch release to the Swiss Market.
* Authorize return to saleable stock or destruction of returned medicines.
* Contact person for and approval of Technical/Quality Agreements related to 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.
* Manage recalls and oversee product quality complaints.
* Report quality issues to Swissmedic within required deadlines.
* Handle quality issues with the responsible Warehouse/Supplier/Manufacturing Site.
* Remain up‑to‑date with Swiss regulatory requirements and processes.
* Act as contact person for all quality issues for AbbVie AG related to Swissmedic, the Cantonal Health Authority, RFS and Third‑Party Manufacturers.
* Plan and perform internal audits.
* Ensure Site Quality Compliance Metrics are reported periodically to Site Management.
* Ensure employees involved in distribution activities perform a GDP refresher training at least annually.
* Participate in a course, seminar, congress or equivalent focusing on GMP/GDP at least once a year.
* Assess education and experience of the Deputy FvP and assign delegation.
Qualifications
* Degree in Chemistry, Pharmacy, Biology, another technical/scientific area, MBA or M.S. preferred.
* Minimum 5 years’ experience in quality assurance, operations or related areas, with proven experience in Good Distribution Practice (GDP). Management experience preferred.
* Full understanding of local GxP requirements and deep knowledge of specific elements.
* General knowledge of AbbVie MD, pharmaceutical, biologic and cosmetic products and regulations, including therapeutic uses and strategic importance.
* Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations.
* Professional training and experience to be accepted by authorities as FvP.
* Ability to coach and develop others, invest in people and build talent.
* Make decisions with minimal direction within scope of role.
* Result‑driven, prioritizing continuous improvement.
* Influencing skills with stakeholder engagement and negotiation.
* Leadership presence, team motivation and relationship building.
* Business acumen linking QA to broader business objectives.
* Familiarity with SAP, TrackWise, ComplianceWire, OneVault.
* Excellent written and oral communication skills.
* Proficiency in English and German.
AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.
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