Commercial Quality Lead, Qp

vor 2 Wochen

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

  • Em Quality Category Lead

    Vor 4 Tagen

    Zug, Schweiz Kenvue Vollzeit

    Description **External Manufacturer Quality Category** **Leader** **Physical Location of Role**: Zug CH - The External Manufacturing (EM) Quality Category Leader is responsible for the quality oversight and coordination of activities related to the EM category. This individual is accountable for developing and leading the execution of a quality strategy...

  • Sr. Manager Quality Assurance

    vor 4 Wochen

    Zug, Schweiz Apellis Vollzeit

    **Position Summary**: The Senior Manager Quality Assurance is responsible for providing the quality oversight of routine GMP batch production activities at our Contract Service Provider (CSP) located in Switzerland. The Senior Manager Quality Assurance will have a strong scientific background/ education which will enable him/ her to be the point of contact...

  • Sr. Manager Quality Assurance

    vor 4 Wochen

    Zug, Schweiz Apellis Pharmaceuticals Vollzeit

    **Position Summary**: The Senior Manager Quality Assurance is responsible for providing the quality oversight of routine GMP batch production activities at our Contract Service Provider (CSP) located in Switzerland. The Senior Manager Quality Assurance will have a strong scientific background/ education which will enable him/ her to be the point of contact...

  • Lead Counsel, International

    vor 4 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...

  • Manager, External Quality Operations

    vor 1 Tag

    Zug, Schweiz Seagen Vollzeit

    Position Summary: Principal Responsibilities: - Serve as Quality Single Point of Contact on one or more internal Virtual Management Teams consisting of Technical Development, Quality, Planning, Logistics, and Manufacturing Sciences & Technology representatives - Develop, negotiate and maintain Quality Agreements with CMO and ensure compliance with...

  • Senior Program Manager Quality

    vor 4 Wochen

    Zug, Zug, Schweiz SHL Medical AG Vollzeit

    April 15, 2024 Full TimeZug SwitzerlandSenior Program Manager QualityJob OverviewThe Senior Program Manager Quality will play a vital role in the Quality organization and will lead an organizational development program of high complexity, team size, and responsibility. The program consists of a project portfolio of multiple transformation projects whereas...

  • Sr. Manager, Commercial Insights

    Vor 3 Tagen

    Zug, Schweiz Deciphera Pharmaceuticals Vollzeit

    Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative...

  • Senior Program Manager Quality

    vor 3 Wochen

    Zug, Schweiz SHL Group Vollzeit

    Job Overview The Senior Program Manager Quality will play a vital role in the Quality organization and will lead an organizational development program of high complexity, team size, and responsibility. The program consists of a project portfolio of multiple transformation projects whereas the (Senior) Program Manager utilizes advanced program...

  • Global Process Owner Leader

    Vor 4 Tagen

    Zug, Schweiz Kenvue Vollzeit

    Description The Global Process Owner Leader is responsible for the implementation and oversight of a GPO model within Quality Health & Safety (QHS) at Kenvue. This individual is responsible for ensuring Global Process Owners are in place for all key Quality and Safety Management System (QSMS) processes, to ensure simplification and standardization of...

  • Quality Release Lead

    vor 3 Wochen

    Zug, Schweiz Michael Page Vollzeit

    The selected candidate is responsible for ensuring that each individual batch has been manufactured in compliance with laws in force in the country of destination, in accordance with the requirements of the marketing authorization and with good manufacturing practice, by carrying out the following task areas:Reviews and verifies batch release documentation...

  • Commercial Excellence

    vor 4 Wochen

    Zug, Schweiz Ardagh Group Vollzeit

    Commercial Excellence & Sales Controlling Director (M/F/d) This role will strengthen the senior management and commercial organization across the regions by increasing our capabilities to drive profitable growth opportunities and optimizing our sales efforts. This role will support usage of tools and implement processes to foster commercial excellence...

  • International Marketing Director

    vor 4 Wochen

    Zug, Schweiz Deciphera Pharmaceuticals Vollzeit

    Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative...

  • Senior Quality Engineer Risk Management

    vor 3 Wochen

    Zug, Schweiz SHL Group Vollzeit

    Job Overview The Risk Leader is responsible for reviewing risk management-related topics within Design and Development Projects and participates in the development, implementation, and administration of SHL’s risk management processes. This is a Switzerland – based role that will work across the global organization and collaborate with...

  • Deployment Lead J&j Production System Director

    vor 4 Wochen

    Zug, Schweiz Johnson & Johnson Vollzeit

    This role is part of a Deployment Team to support implementation of the J&J PRODUCTION SYSTEM (JJPS) and to improve effectiveness and efficiency of MAKE processes. Overall responsibilities will include the deployment on request, of the JJPS Business Process Standards across all segments and franchises of MedTech and Innovative Medicines, from the request for...

  • Brand Manager and Launch Lead Prescription

    vor 3 Wochen

    Zug, Schweiz Galderma Vollzeit

    Description Key Responsibilities Lead the development and execution of strategies for key in-market prescription brands, aligned with global and regional guidance. Collaborate closely with internal cross-functional colleagues and external stakeholders to drive targeted Integrated Dermatology Strategy initiatives. Design and implement market...

  • Regulatory Advertising and Promotion Lead

    vor 4 Wochen

    Zug, Schweiz Apellis Pharmaceuticals Vollzeit

    **Title: Associate Director, International Advertising and Promotion Regulatory Affairs** **Location: Zug or remote (Europe)** **Reporting: Senior Director, International Regulatory Affairs** **Description**: - The Associate Director of International Advertising and Promotion (A&P) serves as an internal expert on industry codes and guidance and...

  • Emea Sustainable Packaging Lead

    vor 4 Wochen

    Zug, Schweiz Kenvue Vollzeit

    **EMEA Sustainable Packaging Lead**-2307008933W Description **EA Sustainable Packaging Lead**: **Locations: At our R&D sites in Switzerland, France, UK, Germany** **Who we are**: **At **Kenvue**, part of the Johnson & Johnson Family of Companies, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled...

  • Director Site Supply Operations

    vor 4 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...

  • Global Medical Affairs Lead, Hematology

    Vor 4 Tagen

    Zug, Schweiz GSK Vollzeit

    **Site Name**: USA - Massachusetts - Waltham, GSK House, Switzerland - Zug, USA - Pennsylvania - Upper Providence **Posted Date**: May 16 2023 **Overview** The Global Medical Affairs Lead (GMAL) will be at the forefront of GSK’s re-emergence in discovering and providing cutting edge Oncology treatments. The person taking on this role will work closely...

  • Lead Operator, Private Equity Technology

    Vor 5 Tagen

    Zug, Schweiz Partners Group Vollzeit

    **What it's about** You will be a part of the Technology vertical team within the Private Equity department of Partners Group, a leading global private markets investor. This role offers you the opportunity to shape Partners Group’s strategy for how to make the most of opportunities created by the rapid pace of technological innovations and...