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Commercial Quality Lead, Qp

vor 5 Monaten

Zug, Schweiz Kenvue Vollzeit

**Commercial Quality Lead, QP**-2206092744W

**Description**

**Commercial Quality Lead / Qualified Person (M/F/d) Full time**

As Commercial Quality Lead you ensure compliance of our products with the Swiss legislation and corresponding guidelines. As a Qualified Person (Fachtechnisch verantworliche Person) according to article 5 / 6 HMG, you are responsible for the release of our medicinal products. You monitor GMP-compliant production and quality control, change management and deviations for the products in the area of responsibility.
Furthermore, in this role you will supervise the compliance of the Marketing Authorization Holder and the Wholesale License Owner for our Consumer companies in Switzerland, while developing, maintaining and continuously improving the Quality Management System.

Main responsibilities
- Release of Medicinal Products as a Qualified Person according to article 5 / 6 HMG
- Ensure compliance of the manufacturing process with the Marketing Authorization and GMP
- Maintain overview of the entire supply chain of the Active Substance and Medicinal Product
- Review and approve change requests, deviation reports; support in the definition and implementation of immediate and further actions (CAPAs)
- Support in complaint process; ensure that relevant customer complaints are dealt with effectively
- Coordination of any Field Alert or recall operations for Medicinal Products
- Lead the preparation and execution of internal audits and regulatory inspections and its follow up
- Perform and follow up of internal and supplier audits, support of issue and revision of Quality Agreements
- Perform and approve PQR reviews
- Lead the compliance of our Swiss Hub distributor businesses

**Qualifications**

Qualifications - External
- Professional degree as Pharmacist or an equivalent education in Natural Sciences and min 3 years’ experience in a Quality and Compliance environment of pharmaceutical industry
- Qualified Person according to Swiss medicinal products regulations (Fachtechnisch verantwortliche Person gemäß article 5 / 6 HMG) or “ready to be” relevant experience in QA/QC/QM
- Significant knowledge and experience with quality systems and guidelines (GMP, GDP, ISO)
- Excellent understanding of regulatory requirements and legislation (Swiss legislation and corresponding guidelines)
- Proficient English and at least intermediate German language skills
- Good Knowledge of Microsoft Office software: Excel, Word, PowerPoint, Acrobat
- Good analytical skills, capability for problem solving and working in cross functional and international teams, good organization talent and presentation skills combined with excellent written and verbal communication skills

**Primary Location** Europe/Middle East/Africa-Switzerland-Zug-Zug

**Organization** Johnson & Johnson GmbH

**Job Function** Compliance