Commercial Quality Lead, Qp

Vor 2 Tagen

Zug, Schweiz Johnson & Johnson Vollzeit

For the next possible date, we are looking for a

**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**:

- 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

  • Director Commercial Quality, Emea

    Vor 2 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson Consumer Health is recruiting for an exciting role of Director, Commercial Quality, EMEA. Our Consumer Health companies produce many of the world's most trusted brands, among them TYLENOL®, MOTRIN®, LISTERINE®, NEUTROGENA®, NICORETTE®, LE PETIT MARSEILLAIS®, NEOSTRATA® and DR CI:LABO®. Each one of our consumer businesses adopts...

  • Commercial Quality Manager Emea

    Vor 2 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson is currently recruiting for a Commercial Quality Manager EMEA (New Consumer Health Company). This position may be located in Zug, Switzerland; High Wycombe, England; the Czech Republic; or Belgium. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and...

  • Commercial Lead Switzerland

    vor 1 Woche

    Zug, Schweiz IPSEN Vollzeit

    **Title**: Commercial Lead Switzerland **Company**: IPSEN Pharma Schweiz GmbH The Commercial Lead coordinates and leads the business in CH or AT, reporting into the GM DACH. Reporting into him/her directly are the CHAT Sales Manager, the Market Access KAM in CH and AT respectively as well as the HR/Executive Assistant located in CH. The Medical Manager in...

  • Senior Quality Assurance Manager

    vor 2 Wochen

    Zug, Zug, Schweiz Viatris Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    Viatris Pharma GmbHAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access – Providing high quality trusted medicines regardless of...

  • Manager, Quality Compliance

    vor 2 Wochen

    Zug, Schweiz Seagen Vollzeit

    Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to...

  • Lead Counsel

    vor 2 Wochen

    Zug, Schweiz Exact Sciences Corporation Vollzeit

    Position Overview The Lead Counsel, International Corporate plays a leading role in complex commercial contracting and licensing matters, as well as business development activities outside the United States. The incumbent oversees the company’s ex-U.S. commercial contracting, including by managing other lawyers and liaising with the Company’s broader...

  • Commercial Manager

    vor 2 Wochen

    Zug, Schweiz SAM International GmbH Vollzeit

    For our client, a leisure company based in Zug, Switzerland, we are looking for a hands-on Commercial who will be a key player in growing the business. Tasks - You will in liaison with the market manager and management group be responsible for Denmark’s and other countries' expansion strategy and execution - Developing annual market/country plan,...

  • Director, International Commercial Operations and Launch Excellence Lead

    Vor 6 Tagen

    Zug, Schweiz Blueprint Medicines Corporation Vollzeit

    **Location(s)**: Zug, Switzerland** **Level of position**: Director** **Position type**:**office-based**, in alignment with**BlueFlex** model**/field-based** **Reporting Line**:**Vice President, International Commercia**l** **How will your role help us transform hope into reality?** - Blueprint Medicines International team is looking for a talented...

  • Vice President, Data Value and Quality

    Vor 4 Tagen

    Zug, Schweiz Thomson Reuters Vollzeit

    As Vice President of Data Value and Quality at Thomson Reuters, you will lead enterprise-wide initiatives that unlock the full business potential of our data assets. This is a strategic leadership role focused on driving commercial value from foundational data, with a core emphasis on customer, product, and content data across our technology platforms. You...

  • Senior Product Analyst – SAP QM

    vor 2 Wochen

    Zug, Schweiz Johnson & Johnson AG Vollzeit

    A leading global healthcare company located in Switzerland is seeking a Lead Product Analyst - Make QM. This position involves acting as a Business Analyst for SAP S/4HANA, supporting manufacturing quality management processes and collaborating with global teams. The ideal candidate will have 3+ years of relevant IT Business Analysis experience, along with a...