Global Quality Compliance Manager
vor 4 Wochen
For one of our clients, an international company in Canton de Vaud, we are looking for a** Global Quality Compliance Manager**
Missions:
- Collaborate to ensure Compliance of the Global QMS to the most current version of applicable International Medical Product, Regulations and Standards through effective implementation, training, and monitoring.
- Support the Global Internal and External Audit Programs including Interface with external agencies as required including the FDA and the Notified Body.
- Partner with Global Regulatory Affairs to assure integration of Regulatory Intelligence activities and changing expectations into the QMS
- Support the development, execution, and delivery of global quality compliance strategies.
- Partner with Quality Site Heads, Global Quality Functions, R&D, Supply Chain, Operations & Marketing to assure Global Compliance Objectives are identified and fulfilled.
- Drive continuous improvement in the overall compliance profile
- Continually evaluate the site activities for Compliance to Quality Standards and Regulations.
- Identify where corrections or improvements are indicated
- Provide support to other departmental activities as directed.
- Provide Subject Matter Expertise in evaluation and implementation of domestic and international regulatory GMP requirements.
- Support the development of company-wide Quality compliance roadmap and define priorities in line with global requirements and existing compliance gaps including the development, installation and monitoring of Global Quality Policies and Procedures
- Collaborate to define global processes & support the site Quality Heads to ensure execution on site level, supporting the site leaders as needed
- Facilitate the harmonization of quality compliance standards and ensure they are aligned across functions
- Collaborate with Global Site Quality Leaders to implement digital strategies for Global Quality and Compliance Data
- Support the installation of a global system for routine review of quality system data, including internal/external audit results to determine compliance gaps and associated mitigation plans on a global level
**Profile**:
**Bachelor’s Degree or Equivalent, Master’s Degree Preferred**
Minimum 5 years of proven experience in the field of medical devices
Knowledge of applicable **ISO Standards ISO13485, ISO 9001, ISO14971, the Medical Device Directive 93/42/EEC, 2017/745 Medical Device Regulation other relevant European directives, general knowledge of US Quality System** Regulations and other applicable Country regulations worldwide
BOOST
-
Global Supply Chain Quality Manager
Vor 7 Tagen
Lausanne, Schweiz LHH Vollzeit**Global Supply Chain Quality Manager - Based in Western Switzerland** - Support the development, execution, and delivery of global s**upply chain quality **strategies for the company. Partner with Quality Site Heads, Global Quality Functions, R&D, **Supply Chain**, Operations & Marketing to assure** Global Supply Chain **Objectives are identified and...
-
Quality Assurance Manager
vor 1 Monat
Lausanne, Schweiz Panda International Vollzeit**Quality Assurance Manager**: **Location** - Lausanne, Switzerland **Business Sector** - Biotechnology **Job ref** - 22069 **Published** - about 1 month ago Our client, a renowned leader in the field of immunotherapy, dedicated to pushing the boundaries of science to transform the lives of patients is currently seeking a highly experienced and strategic...
-
Quality Assurance Manager
vor 1 Woche
Lausanne, Schweiz Panda International Vollzeit**Quality Assurance Manager**: **Location** - Lausanne, Switzerland **Business Sector** - Biotechnology **Job ref** - 22069 **Published** - about 1 month ago Our client, a renowned leader in the field of immunotherapy, dedicated to pushing the boundaries of science to transform the lives of patients is currently seeking a highly experienced and strategic...
-
Quality Director
Vor 2 Tagen
Lausanne, Schweiz GTX medical VollzeitAt ONWARD we're looking for a Quality Director to join our team. Full-time - Lausanne **About the job**: The Director Quality develops and implements the Global Quality strategy and ensures global alignment to ONWARD Medical’s Quality Management System. As head of the Quality Team the Director Quality is responsible for the corporate Quality Management...
-
Data Quality Expert
vor 3 Wochen
Lausanne, Schweiz Talan VollzeitJob DescriptionThe Data Quality Specialist uses best practices and tools to analyze and measure data quality and develop action plans to ensure data reliability, completeness, and consistency. The Data Quality Specialist role will support the Data Governance team in driving governance policies across all R&D business functions and support compliance with...
-
Data Quality Expert
vor 3 Wochen
Lausanne, Schweiz Talan Vollzeit**Company Description** For 20 years, Talan has advised major companies and administrations, supported them, and implemented their transformation and innovation projects. The Group places innovation at the heart of its development and operates in areas related to technological changes, such as Big Data, IoT, Blockchain and Artificial Intelligence. Present...
-
Lausanne, Schweiz Debiopharm VollzeitDebiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative...
-
Data Quality Expert
vor 3 Wochen
Lausanne, Schweiz Talan VollzeitCompany Description For 20 years, Talan has advised major companies and administrations, supported them, and implemented their transformation and innovation projects. The Group places innovation at the heart of its development and operates in areas related to technological changes, such as Big Data, IoT, Blockchain and Artificial Intelligence. Present...
-
Quality Assurance Manager
vor 1 Monat
Lausanne, Schweiz Limula VollzeitLimula SA is a Life Science start-up based in Lausanne, Switzerland. Our company was established with _the mission to help bring the most personalised cancer treatments to the patients in need, at reasonable _cost, wherever they are. To achieve this goal, our multidisciplinary team provides a unique cell processing _solution that enables the production of...
-
Head of Quality
vor 2 Wochen
Lausanne, Schweiz LHH Vollzeit**Head of Quality - Medical devices - Vaud** For one of our clients, a medical devices company based in Canton de Vaud, LHH Recruitment Solutions is recruiting a **Head of Quality in Medical Devices**. The Head of Quality will be responsible to manage **Quality Assurance, Quality Control** and **Quality **support to manufacturing, Validation teams and...
-
QA Operations Manager
Vor 2 Tagen
Lausanne, Schweiz Axepta SA VollzeitMy client a growing international medical device company is looking for a **Quality Operations Manager to join one of their office based in Vaud canton.** **Responsibilities**: - Direct and manage the QA operations team - Coach and mentor employees to optimum performance, and recruit and interview qualified applicants, ensure appropriate new-hire training...
-
Clinical Development Quality Lead
Vor 4 Tagen
Lausanne, Schweiz Coopers Group AG Vollzeit**Clinical Development Quality Lead** You will lead the implementation of the quality startegy within Clinical Development. **Responsibilities** - Managing document & data accuracy (eCTD Module 5) - CRO/Vendor selection and qualification process - Collaborate with the Clinical Trial Manager and Study Teams - Compliance oversight on clinical quality -...
-
Clinical Development Quality Lead
vor 3 Wochen
Lausanne, Schweiz Hobson Prior Vollzeit**Salary**: CHF140000 - CHF150000 per annum**Job type**: Permanent **Location**: Lausanne, Switzerland **Function**: Quality Assurance, Quality Systems **Posted**:20/06/2023 **Ref**: BBBH22811 - Hi I'm Ingrid , I manage this role Hobson Prior are currently seeking for a Clinical Development Quality Lead to join a fantastic biopharmaceutical...
-
Clinical Development Quality Team Lead
Vor 6 Tagen
Lausanne, Schweiz Debiopharm VollzeitDescription Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...
-
P2308 - Global Program Head Anti-infectives
Vor 7 Tagen
Lausanne, Schweiz Debiopharm VollzeitDescription Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...
-
P2308 - Global Program Head Anti-infective
Vor 7 Tagen
Lausanne, Schweiz Debiopharm Vollzeit**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop...
-
Global Category Development Senior Manager
Vor 2 Tagen
Lausanne, Schweiz Nestlé Operational Services Worldwide SA VollzeitThe Nestlé Group is the world's largest food and beverage company with 92.6 billion Swiss Francs in sales in 2019. It is present in 187 countries around the world, has 403 factories and its 291'000 employees are committed to Nestlé's purpose of enhancing quality of life and contributing to a healthier future. Nestlé offers a wide portfolio of products and...
-
Global Category Development Senior Manager
Vor 6 Tagen
Lausanne, Schweiz Nestlé Operational Services Worldwide SA VollzeitThe Nestlé Group is the world's largest food and beverage company with 92.6 billion Swiss Francs in sales in 2019. It is present in 187 countries around the world, has 403 factories and its 291'000 employees are committed to Nestlé's purpose of enhancing quality of life and contributing to a healthier future. Nestlé offers a wide portfolio of products and...
-
Global Category Development Senior Manager
Vor 4 Tagen
Lausanne, Schweiz Nestlé Operational Services Worldwide SA VollzeitThe Nestlé Group is the world's largest food and beverage company with 92.6 billion Swiss Francs in sales in 2019. It is present in 187 countries around the world, has 403 factories and its 291'000 employees are committed to Nestlé's purpose of enhancing quality of life and contributing to a healthier future. Nestlé offers a wide portfolio of products and...
-
P2313 - Clinical Development Quality Lead
vor 1 Monat
Lausanne, Schweiz Debiopharm Vollzeit**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop...