Quality Assurance Associate
vor 6 Monaten
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 External Manufacturing and Testing.
**Responsibilities**:
Manage KPI programs for Global Quality Operations and reporting
Coordinate training for Global External Quality teams
Establish and maintain IT tools for executing work to increase effectiveness
Identify and create software solutions for data extraction from different IT systems
Create and maintain a Power BI dashboard for External Quality KPIs
Support new IT system implementation and participate in testing functionality
Serve as a super user for electronic systems such as Veeva and Oracle
Represent the External Quality department as a TOPS Operational Excellence ambassador
Support regulatory inspections as the process owner of the Seagen CMO KPI process
Write and review Standard Operating Procedures as needed
Oversee the Process Improvements projects follow up process in External Quality
Support the implementation of risk management in External Quality
Maintain the quarterly KPI and risk register of CMOs
Provide External quality input to TO’s monthly score card
**Qualifications**:
3+ years of experience in the regulated pharmaceutical industry
Experience in project management and managing global action plans
Good communication skills and proven ability to work well with senior internal and external stakeholders
Experience with electronic documentation management systems preferred
Expertise in Excel, PowerPoint, and other office software
Ability to prioritize work and handle multiple assignments while maintaining a high level of quality
Fluency in English speaking and writing
Education
Master's degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.) or similar
Training in computer science and/or automation is desirable
Interested?
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 External Manufacturing and Testing.
**Responsibilities**:
Manage KPI programs for Global Quality Operations and reporting
Coordinate training for Global External Quality teams
Establish and maintain IT tools for executing work to increase effectiveness
Identify and create software solutions for data extraction from different IT systems
Create and maintain a Power BI dashboard for External Quality KPIs
Support new IT system implementation and participate in testing functionality
Serve as a super user for electronic systems such as Veeva and Oracle
Represent the External Quality department as a TOPS Operational Excellence ambassador
Support regulatory inspections as the process owner of the Seagen CMO KPI process
Write and review Standard Operating Procedures as needed
Oversee the Process Improvements projects follow up process in External Quality
Support the implementation of risk management in External Quality
Maintain the quarterly KPI and risk register of CMOs
Provide External quality input to TO’s monthly score card
**Qualifications**:
3+ years of experience in the regulated pharmaceutical industry
Experience in project management and managing global action plans
Good communication skills and proven ability to work well with senior internal and external stakeholders
Experience with electronic documentation management systems preferred
Expertise in Excel, PowerPoint, and other office software
Ability to prioritize work and handle multiple assignments while maintaining a high level of quality
Fluency in English speaking and writing
Education
Master's degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.) or similar
Training in computer science and/or automation is desirable
Interested?
-
Associate, Quality Assurance
vor 6 Monaten
Zug, Schweiz Seagen VollzeitSeagen 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...
-
Position: Clinical Quality Associate
vor 6 Monaten
Zug, Schweiz Meditrial Europe Ltd. Vollzeit**Company Overview**: Meditrial is a dynamic and rapidly growing multinational company specializing in providing clinical and regulatory services to medical device companies in the USA and Europe. With a commitment to excellence and innovation, we empower our clients to navigate complex regulatory landscapes and bring life-changing medical devices to market...
-
Quality Assurance Specialist
vor 4 Wochen
Zug, Zug, Schweiz SHL Group VollzeitJob DescriptionCompany Overview: SHL Group is a leading global manufacturing company seeking a Quality Assurance Specialist to join our team in Taiwan.Estimated Salary: $60,000 - $80,000 per annum, depending on experience.About the RoleWe are looking for a highly skilled and experienced Quality Assurance Specialist to lead our quality assurance initiatives...
-
Zug, Zug, Schweiz AbbVie VollzeitOverviewAbsorbent and dynamic professional with a strong background in quality assurance is sought to join our team as Quality Product Manager.Job SummaryThis role will be responsible for ensuring end-to-end product quality for designated products, encompassing all aspects associated with manufacturing and testing of designated product components. The ideal...
-
Zug, Zug, Schweiz SHL Group VollzeitSHL Group is seeking a highly skilled Quality Assurance Engineer to join our team in Taiwan. As a key member of our quality assurance and control team, you will be responsible for ensuring the highest standards of quality in our new product implementation manufacturing line. This role requires strong collaboration with cross-functional teams to establish...
-
Associate Medical Writer.
vor 7 Monaten
Zug, Schweiz PSI VollzeitJob Description Writes, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives Collects and tracks documents for CSR appendices, in support of the Quality Control...
-
Quality Assurance Manager for Regulated Industries
vor 4 Wochen
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe SHL Group is seeking an experienced Senior Quality Operations Manager to join our team in Zug. This role plays a crucial part in ensuring the quality of products manufactured at our Swiss site meets required standards.Main ResponsibilitiesEstablish and qualify QC Laboratory, equipment, required tests and inspections to ensure...
-
Senior Quality Assurance and Control Specialist
vor 4 Wochen
Zug, Zug, Schweiz SHL Group VollzeitAt SHL Group, we are seeking a highly skilled Senior Quality Assurance and Control Specialist to join our team. This is a full-time role based in Taiwan, working closely with our global organization and collaborating with stakeholders, internal/external Subject Matter Experts and Industry Authorities.We offer a competitive salary of around $90,000 - $110,000...
-
Zug, Zug, Schweiz Siemens Schweiz AG, Smart Infrastructure, Global Headquarters VollzeitAbout the JobWe are seeking an experienced Software Developer to join our dynamic and motivated development team as a Quality Assurance Engineer for Building Automation. You will be responsible for analyzing current testing processes and practices, driving improvements in a key project portfolio in the environment of building automation, and ensuring...
-
Compliance Assurance Specialist
vor 1 Monat
Zug, Zug, Schweiz AbbVie VollzeitWe are seeking a highly skilled Compliance Assurance Specialist to join our team at AbbVie.Job OverviewThis role is responsible for ensuring compliance with regulatory requirements and industry standards in the import and wholesaling of medicinal products.About the RoleThe ideal candidate will have 5+ years of experience in quality assurance, operations, or...
-
Associate Director Pharmacovigilance International
vor 6 Monaten
Zug, Schweiz Apellis Pharmaceuticals Vollzeit**The role can be based in Munich, Germany or Zug, Switzerland** **Position Summary**: The Associate Director Pharmacovigilance (PV) International is responsible for managing local PV processes and systems in ex-US territories (focusing on Europe), maintaining compliance with local/regional PV regulations and guidance, particularly EU Good Pharmacovigilance...
-
Head of Quality Assurance Switzerland
vor 4 Wochen
Zug, Schweiz Viatris VollzeitViatris Pharma GmbH At 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...
-
Desktop Quality Assurance Expert
vor 4 Wochen
Zug, Zug, Schweiz Status VollzeitStatus is a company that aims to build tools and infrastructure for the advancement of a secure, private, and open web3. Our goal is to preserve the right to privacy, mitigate the risk of censorship, and promote economic trade in a transparent, open manner.We are building a community where anyone can join and contribute. As an organization, Status seeks to...
-
Global Quality Systems Manager
vor 4 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...
-
Director, Quality Management.
vor 6 Monaten
Zug, Schweiz PSI VollzeitJob Description Resource Management and Training: Participation in QM resource allocation Resource allocation of QA auditors Facilitation of professional development and career advancement of Quality Management staff Administrative supervision of Quality Management staff, jointly with Senior Director Quality Management Participation in...
-
Director Global Quality
vor 6 Monaten
Zug, Schweiz SHL Medical AG Vollzeit**Job Overview** The position of the Director global Quality of SHL Medical AG holds overall responsibility for compliance to all applicable regulations pertaining to all operations functioning on the assigned site as well as corporate compliance to all applicable regulations including cGMP pertaining to all the markets currently being served by the...
-
Senior Quality Operations Director
vor 4 Wochen
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe Senior Quality Operations Manager plays a pivotal role in ensuring products manufactured at SHL Swiss sites meet quality, reliability, and regulatory standards.This position involves managing QA and QC personnel, establishing, qualifying, and managing QC/QA processes, flow, equipment, and tools at the manufacturing facility in Zug.Main...
-
Quality Partner
vor 6 Monaten
Zug, Schweiz ITech Consult Vollzeit**Quality Partner (m/w/d) - Quality Assurance / ISO 13485 / FDA Regulation / Prozess-Risikoanalysen / Deutsch** **Projekt**: Für unseren Kunden Roche Diagnostics International AG mit Sitz in Rotkreuz suchen wir einen Quality Partner (m/w/d) **Hintergrund**: Für das Operations Quality Netzwerk RDI/RDA suchen wir für das Product Partnering im Bereich BG&E...
-
Vice President, Quality International
vor 2 Wochen
Zug, Schweiz Hologic, Inc. VollzeitJob Title: Vice President of International QualityCompany: Hologic, Inc.Location: Belgium (could also consider Zug, Switzerland or Cambridge, UK)Position Overview: We are seeking an accomplished and strategic Vice President of International Quality to lead our quality assurance and control initiatives ensure compliance to global QMS and regulations. This key...
-
Senior Quality Operations Manager
vor 4 Wochen
Zug, Schweiz SHL Group VollzeitJob Overview The Senior Quality Operations Manager plays a crucial role in ensuring that products manufactured at SHL Swiss site meet required standards of quality, reliability, and regulatory. This position involves managing the team of QA and QC personnel, establishing, qualifying and managing the operations of QC/QA processes, flow, equipment &...