Quality Assurance Lead

Vor 3 Tagen

Lausanne, Waadt, Schweiz Incyte Vollzeit

Incyte seeks a highly skilled Quality Assurance Lead to oversee the company's Quality compliance and drive quality performance across various GxP disciplines. This critical role plays a vital part in ensuring the company's commitment to bringing innovative solutions to patients.

The successful candidate will develop and maintain strategic Quality documentation, including the Quality Manual and Policies, and establish a comprehensive GxP quality risk management system. This will enable the company to properly identify, manage, mitigate, and escalate Quality risks.

This position will own core Quality processes, such as Deviation, Change control Management, CAPA, ensuring their continuous compliance and performance supporting GxP operations. The lead will also develop a robust data governance program to ensure reliability, integrity, and quality of GxP quality information.

The Sr Manager will support the execution of the GxP audit program as a Senior auditing resource and contribute to best practices definition for audit management.

Key Responsibilities:

  • Quality Risk Management (QRM) :
    • Develop, implement, and maintain a comprehensive GxP quality risk management system.
    • Own the company's GxP quality risk register and monitor mitigation.
    • Support other Facilities/Departments in implementing QRM, facilitate risk assessments, and ensure appropriate documentation and follow-up actions.
    • Train staff on QRM and associated tools.
  • Quality Manual & Policies :
    • Develop and maintain the company's quality manual and policies.
    • Ensure all quality policies are in compliance with regulatory requirements and industry standards.
    • Communicate and enforce quality policies across the organization.
  • Quality Systems :
    • Own the following quality processes: Deviation Management, Change Management, and Corrective and Preventive Actions (CAPA) Management.
    • Oversee the implementation and monitoring of these processes to ensure compliance and continuous improvement.
    • Identify e-system enhancements needs and partner with digital Quality and IT to implement.
    • Manage the process training strategy.
    • Define and monitor metrics to assess the process performance and compliance.
  • Audit Execution :
    • Support the execution of the Incyte internal and external GxP audit programs.
    • Contribute to best practices definition for audit management.
  • Data Integrity, Data Quality, and Data Governance :
    • Implement and maintain GXP data governance policies and procedures.
    • Ensure data integrity, quality, and governance across all QA processes and systems.
    • Define requirements for data quality and ensure their implementation.
    • Monitor data quality and address any issues or discrepancies promptly.
  • Inspection Program :
    • Act as SME during inspections/audits.
    • Support received audits, including inspections, hosted by the company's facilities.

Qualifications

  • Bachelor's degree in Quality Management, Pharmacy, Life Sciences, or a related field. Advanced degree preferred (Master's Degree).
  • Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
  • In-depth knowledge of quality management systems, quality standards (e.g., GMP, GLP), and pharmaceutical regulations (e.g., FDA, EMA) in at least two GxP areas.
  • Qualified auditor.
  • Excellent analytical and problem-solving skills.
  • Proficiency in quality management software and tools.
  • Proven experience in Risk Management.
  • Ability to work in a dynamic environment and handle multiple projects simultaneously.
  • Strong commitment to maintaining high-quality standards and continuous improvement.

  • Quality Assurance Engineer

    vor 1 Tag

    Lausanne, Waadt, Schweiz Qim info SA Vollzeit

    As a leading IT services company in Switzerland, Qim info SA has established itself as a trusted partner for organizations seeking innovative solutions. With over 15 years of experience, we've built a strong reputation for delivering high-quality services that meet the evolving needs of our customers.We're currently seeking a skilled FMEA expert to join our...

  • Quality Assurance Specialist

    Vor 3 Tagen

    Lausanne, Waadt, Schweiz Andritz AG Vollzeit

    Job Title: Quality Assurance SpecialistWe are seeking a Quality Assurance Specialist to support our engineering departments in the preparation of inspection and test plans.This role involves contributing to supplier manufacturing kick-offs, monitoring the progress of supplier manufacturing, checking and validation of in-process quality documentation, and...

  • Senior Quality Assurance Specialist

    vor 1 Tag

    Lausanne, Waadt, Schweiz The Biopôle Vollzeit

    About The BiopôleThe Biopôle is a dynamic and innovative organization dedicated to the development and implementation of quality assurance processes. Our team is committed to ensuring the highest standards of quality in the medical device industry.Job DescriptionWe are seeking an experienced Quality Engineer to join our team as a Senior Quality Assurance...

  • Quality Assurance Professional

    Vor 3 Tagen

    Lausanne, Waadt, Schweiz Medtronic Vollzeit

    At Medtronic, we are seeking a highly motivated Quality Assurance Professional to join our team in Tolochenaz, Switzerland. This individual will be responsible for ensuring the quality of our products and compliance of our processes at the Swiss Medtronic Operations (SMO) site.In this role, you will work closely with a dynamic team of professionals to drive...

  • Quality Assurance Automation Professional

    Vor 3 Tagen

    Lausanne, Waadt, Schweiz Merck KGaA, Darmstadt, Germany Vollzeit

    We are seeking a Quality Assurance Automation Professional to join our team in Lausanne. As a Quality Assurance Automation Professional, you will be responsible for designing, developing, and maintaining automated test frameworks and scripts.You will collaborate with the development team to integrate automated tests into the CI / CD pipeline. Your goal will...

  • Quality Assurance Engineer

    Vor 7 Tagen

    Lausanne, Waadt, Schweiz GXP CONSULTING Switzerland Vollzeit

    Direct message the job poster from GXP CONSULTING SwitzerlandDo you have a passion for Life Sciences? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? so do weGXP CONSULTING Switzerland is a Swiss consulting company with an experienced team of Life Sciences...

  • Freelance Quality Assurance Professional in MedTech

    Vor 7 Tagen

    Lausanne, Waadt, Schweiz Panda International Vollzeit

    Panda International is a dynamic company in the MedTech industry, dedicated to developing innovative products that meet the highest standards of safety, quality, and regulatory compliance. We are seeking a Freelance Quality Assurance Professional to support our growing team and ensure product quality and regulatory adherence.ResponsibilitiesThe successful...

  • Quality Assurance Operations Specialist

    Vor 7 Tagen

    Lausanne, Waadt, Schweiz GXP CONSULTING Switzerland Vollzeit

    Job Description:GXP CONSULTING Switzerland is a Swiss consulting company with an experienced team of Life Sciences professionals.We deliver outstanding industry's expertise and support to our clients in the complete range of product life cycle.To continue successfully supporting our many clients, we are currently looking for a Quality Assurance Engineer.The...

  • Quality Assurance Engineer

    vor 16 Stunden

    Lausanne, Waadt, Schweiz GXP CONSULTING Switzerland Vollzeit

    Do you have a passion for Life Sciences? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? so do we GXP CONSULTING Switzerland is a Swiss consulting company with an experienced team of Life Sciences professionals. Since 2014 we deliver outstanding industry's...

  • Quality Assurance Engineer

    vor 1 Woche

    Lausanne, Waadt, Schweiz GXP CONSULTING Switzerland Vollzeit

    Do you have a passion for Life Sciences? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? so do weGXP CONSULTING Switzerland is a Swiss consulting company with an experienced team of Life Sciences professionals. Since 2014 we deliver outstanding industry's...

  • Life Sciences Quality Assurance Expert

    vor 1 Woche

    Lausanne, Waadt, Schweiz GXP CONSULTING Switzerland Vollzeit

    GXP Consulting Switzerland is a Swiss consulting company with an experienced team of Life Sciences professionals.We deliver outstanding industry expertise and support to our clients in the complete range of product life cycle.Our success depends on collaboration, sharing expertise, and continuous learning. We are looking for a Quality Assurance Engineer...

  • Software Quality Assurance Specialist

    Vor 2 Tagen

    Lausanne, Waadt, Schweiz Qim info SA Vollzeit

    Qim info SA is seeking a skilled Software Quality Assurance Specialist to join our team. As a key member of our team, you will be responsible for leading the evolution of Solution Release testing and execution of acceptance test phases with the primary objective to increase quality and efficiency.Key Responsibilities:Based on the proposed ATM Release change...

  • Quality Assurance Expert for Medical Devices

    Vor 7 Tagen

    Lausanne, Waadt, Schweiz Panda International Vollzeit

    We are seeking a seasoned Quality Assurance expert to join our team at Panda International. As a key member, you will play a vital role in ensuring the quality and regulatory compliance of our medical devices.Job DescriptionThe ideal candidate will possess a strong background in MedTech, FDA regulations, and 510(k) submissions. They should have experience...

  • Senior Quality Assurance Engineer Role

    Vor 7 Tagen

    Lausanne, Waadt, Schweiz GXP CONSULTING Switzerland Vollzeit

    About the Job:Reviews batch records (API, raw materials, bulk, semi-finished and finished products).Handles deviations, CAPA, and Change Control and ensures the execution and follow up of escalation processes.Writes and assists with writing SOPs and further documents for QA.Qualification and validation documentation (DQ, IQ, OQ, PQ, Cleaning Validation,...

  • Regulatory Compliance Quality Assurance Expert

    Vor 7 Tagen

    Lausanne, Waadt, Schweiz GXP CONSULTING Switzerland Vollzeit

    Requirements:Mid-Senior level professional with experience in Quality Assurance.Master Degree (or equivalent) in Life Sciences or a related discipline.Thorough understanding of cGMPs, Eudralex, and FDA 21 CFR regulatory requirements.Languages: English (fluent), French and/or German is a plus.Benefits:We work as a team where every member is valued and...

  • Clinical Quality Assurance Expert

    Vor 3 Tagen

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Debiopharm is an independent biopharmaceutical company dedicated to improving patient outcomes and quality of life through innovative research in oncology and infectious diseases. Our unique approach combines drug development, manufacturing, and digital health investment to address high unmet medical needs.We are seeking a Clinical Development Quality Lead...

  • Quality Lead in Clinical Development

    vor 18 Stunden

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Innovative Therapies for Unmet Medical NeedsDebiopharm International SA aims to develop novel treatments for complex diseases, focusing on oncology and infectious diseases. Our goal is to improve patient outcomes and quality of life through cutting-edge research and development.We are looking for a Clinical Development Quality Lead to join our team,...

  • Quality Assurance Engineer

    Vor 2 Tagen

    Lausanne, Waadt, Schweiz AgEagle Aerial Systems Inc. Vollzeit

    AgEagle is seeking a highly organized, analytical, team-oriented, and reliable professional with 5-7 years of experience to serve as a Quality Assurance Engineer at our senseFly location in Cheseaux-sur-Lausanne, Switzerland.Responsibilities:Interact with Product Manager and SW team to translate system requirements into a well-structured test plan and test...

  • Quality Assurance Specialist

    Vor 3 Tagen

    Lausanne, Waadt, Schweiz Debiopharm Vollzeit

    Our mission at Debiopharm is to improve patient outcomes and quality of life through innovative research in oncology and infectious diseases. As a Clinical Development Quality Lead, you will play a vital role in ensuring the quality and compliance of our clinical trials.Clinical Development Quality LeadKey Responsibilities :The Clinical Development Quality...

  • Biomedical Engineering Quality Expert

    vor 1 Tag

    Lausanne, Waadt, Schweiz The Biopôle Vollzeit

    About The BiopôleThe Biopôle is a leading organization in the medical device industry, dedicated to providing high-quality products and services. Our team is committed to excellence and innovation, and we are seeking an experienced Quality Engineer to join our team as a Senior Quality Assurance Specialist.Job DescriptionIn this role, you will be...