Responsible Person

**Company Description**

The Responsible Person Immunogen GmbH ensures that all business is conducted in compliance with the Swiss law on Medicinal Products, as well as with Immunogen GmbH company policies. The FvP is by law responsible for direct technical supervision of the operation, safety, efficacy and quality of the medicine, and ensures in particular the proper handling of pharmaceutical products, importing and wholesaling in accordance with the rules of Good Distribution Practice (GDP).

**Key responsibilities as Commercial Quality Assurance Head/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 V7 effective from 26 Aug 2024. The FvP has the authority to issue directives within the sphere of her/his responsibilities.
- Supervision of the business and ensure the appropriate wholesaling activities.
- 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 in accordance with the rules of Good Distribution Practice (GDP).
- Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward.
- 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 documentation proving the quality of the traded batches of drug substance, intermediate drug product and bulk product is complete.
- Independently from management, decide on 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 licensed activities of Immunogen Switzerland GmbH.
- Contact person for and approval of Technical/Quality Agreement related to the supply, transportation and wholesale of medicinal products marketed by Immunogen GmbH Switzerland GmbH.
- Quality oversight / auditing of external service providers.
- Management of Health Authority Inspections and Corporate Audits.
- Management of recalls.
- Management of product quality complaints.
- Report quality issues to Swissmedic according to requirements and within deadlines.
- Handle quality issues with the responsible 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 of Immunogen Switzerland GmbH for Swissmedic, the Cantonal Health Authority and Third-Party Manufacturers.
- 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.
- 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.

**Qualifications** Qualifications and experience**:

- Degree in Chemistry, Pharmacy, Biology
- 5+ years’ experience in quality assurance, operations, regulatory or relevant experience. Some supervisory/management experience preferred.
- Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products.
- Strong influencing, motivational, interpersonal and relationship building skills at all levels.
- Excellent written and oral communication skills. Very good written and oral German and English.
- Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded.
- Strong decision making skills.
- Negotiation skills, effective collaboration and ability to anticipate needs and requirements.
- Strong computer skills and knowledge of enterprise systems such as SolTraqs, SAP, Attache and One vault.
- Motivated, communicative and decisive personality
- Excel with self-initiative, collaborative skills, organizational talent and well-structured way of working.
- As holder of the responsibility for the FvP, he/she must have the necessary professional training and experience to be accepted by the authorities for this function.

**Critical skills required for the role**:

- Makes high-quality decisions with less than perfect information
-