Global Quality Systems Manager

vor 5 Monaten

Zug, Schweiz SHL Medical AG Vollzeit

**Job Overview**

The position of Global Quality Systems Manager is responsible for the corporate compliance to all applicable regulations including cGMP. It is part of the leading quality assurance function for the Corporate Quality system. Actively provides guidance to multiple departments and sites regarding compliance to the applicable SHL Corporate Quality and Regulatory procedures including applicable Agency policies and regulations. Job holder is directly involved in the establishment of corporate procedures. Job holder is Project Manager for the establishment of the Corporate Quality Management system and the implementation of the procedures at the different sites.

**Main Responsibilities**:

- Build and maintain the corporate Quality Management System (QMS).
- Lead Corporate Quality Assurance and Regulatory Affairs (QARA) projects.
- Lead and manage corporate quality audits, ensuring compliance with internal and external standards.
- Provide guidance and best practices on site-specific QMS implementation.
- Lead and participate in internal and external audits at various sites.
- Deliver quality-related training sessions to relevant stakeholders.
- Organize and facilitate corporate Management Reviews.
- Track, analyze, and report on Corporate Key Performance Indicators (KPIs).

**Minimum Requirements**:

- At least 5 years of experience in Regulatory Affairs, Clinical Affairs, or Quality Assurance within the medical device industry.
- Proven track record of success and a broad understanding of contemporary quality practices applicable to product development, manufacturing, and commercial operations.
- Demonstrated expertise in designing and implementing quality processes within a medical device manufacturing environment.
- Strong self-confidence and the ability to effectively engage with all levels of the organization.
- Excellent problem-solving and decision-making skills.
- Commitment to operating with the highest standards of ethics and integrity.
- Ability to understand, respect, and adapt to different cultures and market needs.
- Excellent English communication skills, both oral and written.

**Preferred Qualifications**:

- Advanced leadership and team management skills.
- In-depth knowledge of Good Manufacturing Practices (GMP) and other regulatory compliance requirements.
- Proficiency in German, both oral and written.

**Education and Training**:

- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Certified Lead Auditor for ISO 13485 standards.

**We Offer**
- An exciting opportunity in a fast-growing international medical device company
- A modern working environment, with multicultural and dynamic teams
- Flexible working hours and a hybrid remote work policy
- A centrally located office in Zug, very close to the train station

  • Quality Systems Manager Mdr

    vor 2 Wochen

    Zug, Schweiz SHL Group Vollzeit

    SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their...

  • Quality Assurance Associate

    vor 7 Monaten

    Zug, Schweiz Panda International Vollzeit

    QA Associate This position will support the Global data collection automatization activities to improve CMO and suppliers data collection and KPI process establishment. The role reports into the Senior Director of External Quality and sits within a growing External Quality Operations team that is part of our expanding Global Center of Excellence focused on...

  • Global Supplier Quality Strategy

    vor 2 Wochen

    Zug, Schweiz Kenvue Vollzeit

    **Global Supplier Quality Strategy & Performance Sr. Manager **-2206090097W **Description** Kenvue, part of the Johnson & Johnson Family of Companies is recruiting for a **Global Supplier Quality Strategy & Performance Sr. Manager**, located in Zug, Switzerland. The Global Supplier Quality Strategy & Performance, within Global Supplier Quality Management...

  • Director Emea Quality Systems

    vor 2 Monaten

    Zug, Schweiz Johnson & Johnson Vollzeit

    Ethicon is recruiting for a Director, EMEA Quality Systems, located in Zug, Switzerland. Lead the Ethicon Quality Systems processes and organization by: - Ensuring the Ethicon processes in EMEA are effectively maintained achieving a state of compliance across all Ethicon sites. - Providing management with timely and comprehensive quality data that supports...

  • Manager, Quality Compliance

    vor 7 Monaten

    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 Capacity Planning Manager

    vor 4 Monaten

    Zug, Schweiz SHL Medical AG Vollzeit

    **Job Overview** The Global Capacity Planning Manager has the primary responsibility of ensuring that global production capacity in all sites aligns with customer demand across all regions worldwide. During SHL’s transition from a single site approach to a global production setup, this role will develop and implement a global production strategy that...

  • 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...

  • Manager, Global Logistics

    vor 2 Wochen

    Zug, Schweiz Seagen Vollzeit

    Position Summary: Responsible for planning and management of European logistics and warehousing operations. Includes oversight of shipping vendors, and warehousing operations. Responsible for advanced, complex, supply chain logistics. Expected to have extensive knowledge across many functional areas and resources related to European logistics. Acts as...

  • Associate, Quality Assurance

    vor 7 Monaten

    Zug, Schweiz Seagen Vollzeit

    Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are...

  • Senior Quality Operations Manager

    vor 2 Monaten

    Zug, Schweiz SHL Medical AG Vollzeit

    SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their...

  • Global Category Manager

    vor 7 Monaten

    Zug, Schweiz SHL Medical AG Vollzeit

    SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their...

  • Global Category Manager

    vor 7 Monaten

    Zug, Schweiz SHL Medical AG Vollzeit

    SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their...

  • Sr. Manager Medtech Quality Systems

    vor 1 Woche

    Zug, Schweiz Johnson & Johnson Vollzeit

    **EXPERIENCE AND EDUCATION** - Bachelor’s degree in a technical or science-related field or equivalent - Master degree prefered - 8-10 years related experience - 3-5 years QMS specific experience in a management/supervisory role - Auditing experience - Knowledge of 21 CFR 820, ISO 13485, Medical Device Directive (MDD) and Medical Device Regulation (EU...

  • Snr Director Quality

    vor 3 Monaten

    Zug, Schweiz Kenvue Vollzeit

    Description **Snr Director Quality & Compliance** This role assumes overall responsibility and accountability for ensuring Quality & Compliance requirements are effectively implemented and adhered to throughout the end-to-end supply chain operations for the Selfcare portfolio and Franchise. This end-to-end scope includes assurance of Quality and...

  • Supplier Quality Manager

    vor 2 Wochen

    Zug, Schweiz ITech Consult Vollzeit

    **Supplier Quality Manager **(f/m/d) - Audit / Pharma / ISO13485 / SAP / English** **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Supplier Quality Manager (f/m/d). Background: **Tasks & Responsibilities**: - Manage SCARs (Supplier Corrective Action Request) - Supplier Onboarding...

  • Manager, External Quality

    vor 8 Monaten

    Zug, Schweiz Pfizer Vollzeit

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

  • Em Quality Category Lead

    vor 7 Monaten

    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...

  • Quality Integration Leader

    vor 22 Stunden

    Zug, Schweiz Johnson & Johnson Vollzeit

    Consideration for remote employees may be given on a case-by-case basis and if approved by the business. The Ethicon Surgical Care business is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Biosurgery, Ethicon Energy, Ethicon Endomechanics, Ethicon Robotics, Megadyne, NeuWave, and Torax. With annual sales of...

  • Commercial Quality Manager Emea

    vor 2 Wochen

    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 Quality Manager Emea

    Vor 4 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...