Clinical and Pv Quality Assurance Manager

vor 3 Monaten


Genf GE, Schweiz OM Pharma Ltd. Vollzeit

Location: Meyrin, Geneva, CH- Division:
- Division: Quality- Job Type: Permanent role

We are recruiting a** Clinical and PV Quality Assurance Manager **at our headquarters and biotech production site in Geneva. Reporting to the Head of Quality Management, your mission is to ensure that our Clinical and Pharmacovigilance Quality Assurance system meets standards expected by health authorities and global regulatory authorities.

Your main responsibilities are as follows:

- Ensure timely planning, management and execution of risked based CQA - PVQA audit programs (all type of audits including self inspections)
- Implement measures to ensure inspection readiness of Clinical, Pharmacovigilance, Regulatory and Medical activities
- Lead Quality Risk Management Plan for Clinical, Pharmacovigilance, Regulatory and Medical activities.
- Lead GCP and PV Regulatory Inspections
- Oversee/support the management and escalation of Critical Quality Issues and Serious Breaches
- Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance.
- Improve quality systems, priorities and timelines in Clinical and Pharmacovigilance Quality Assurance frame
- Work closely with our clinical teams to support our sponsored clinical trials
- Manage third party service providers

To carry out this mission, we are looking for a person with the following profile:

- Academic degree in health sciences or related field
- At least 3 years of experience in Clinical and PV Quality Assurance in the pharmaceutical industry and/or CRO
- Extensive understanding of interpretation for FDA, EUand ICH regulations (GCP). CFDA is a plus.
- Experience of planning, managing and executing PV and GCP audits
- Fluent in English with gool oral and written skills in French

You are an experienced team player who enjoys working in a fast paced, hands-on and flexible environment. Thanks to your communication and interpersonal skills, you know how to establish collaborative links with different stakeholders. You like to take a step back to analyze situations and propose new strategies. Finally, you define yourself as a solution-oriented and methodical person who drives novelty.

**About Us**:
OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.
The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.



  • Genf, Genf, Schweiz Teoxane SA Vollzeit

    Clinical Project ManagerTeoxane Laboratories, a leading company in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics, is seeking a skilled Clinical Project Manager to join its team.The ideal candidate will have a strong background in clinical operations and project management, with a minimum of 4 years of experience in...

  • Clinical Project Manager

    vor 3 Monaten


    1203 Genf, GE, Schweiz Teoxane Vollzeit

    **Date**:17 sept. 2024 **Lieu**: Genève, Corporate, 1203 **Entreprise**:teoxanesa Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are...


  • Genf, Genf, Schweiz Skyguide Vollzeit

    Job Description:We are seeking a highly experienced Senior Technical Assurance Expert to lead our compliance and quality efforts as a Compliance and Quality Leader at Skyguide.About the Role:This is an exceptional opportunity to join our team as a Senior Technical Assurance Expert, where you will be responsible for ensuring compliance with national and...


  • 1209 Genf, GE, Schweiz International Federation of Red Cross and Red Crescent Societies Vollzeit

    **Vacancy No.** S07589 **Contract Type** International **Application Deadline** 13-Oct-2024 **Job Posted on** 27-Sep-2024 **Country** SWITZERLAND **Duty Station** Geneva, Switzerland **Duty Station Status** Family Duty Station **Duration** 24 months **Accompanied Status** Accompanied **Grade** E1 **Organizational Context**: The...


  • Genf, Genf, Schweiz Cross Systems Vollzeit

    At Cross Systems, we are looking for a proactive expert to join our team as a Quality Assurance Manager. Based in Geneva, you will support our client activities in the banking sector.Key Responsibilities:Perform API testing (manual and automated)Conduct end-to-end testingWork in an agile environment with remote teams and stakeholdersExperience in system...


  • Genf, Genf, Schweiz Sopra Steria Vollzeit

    Job DescriptionAs a Quality Assurance Specialist, you will play a key role in ensuring the high quality of our software products.Conduct thorough testing and quality assurance processes to identify and report defects.Collaborate with cross-functional teams to develop and implement effective quality assurance strategies.Analyze and report on quality metrics...


  • Genf, Schweiz Nonviolent Peaceforce Vollzeit

    Global Programme Development and Quality Assurance Manager (6 months maternity leave coverage)Pay: CompetitiveLocation: GenevaEmployment type: Full-TimeJob DescriptionReq#: 468Job Title: Global Programme Development and Quality Assurance ManagerDepartment: ProgrammingDivision: Programme ImplementationDuty Station: GenevaAbout the CompanyNonviolent Peaceforce...


  • Genf, Genf, Schweiz Teoxane SA Vollzeit

    Job Title: Clinical Project ManagerCompany: Teoxane SAClinical Project Manager Job DescriptionJob Summary: We are seeking a highly skilled Clinical Project Manager to join our team at Teoxane SA. As a Clinical Project Manager, you will be responsible for implementing, executing, and completing clinical research projects sponsored by Teoxane according to...


  • Genf, Genf, Schweiz Teoxane SA Vollzeit

    Main Responsibilities:Lead clinical research projects sponsored by Teoxane SA according to timelines and budget.Ensure compliance to local regulations, GCP regulations, and internal SOPs in clinical projects.Collaborate with cross-functional teams to prepare required study documentations for submission to Ethic Committees and competent authorities.Develop...


  • Genf, Genf, Schweiz randstad - highest Vollzeit

    Job OverviewWe are seeking an experienced Quality Assurance Specialist to join our team at Randstad - Highest. As a key member of our Quality Department, you will play a crucial role in maintaining and enhancing quality assurance processes for critical software in the safety and security domains.About the RoleThis position involves reporting to the Safety,...


  • Genf, Genf, Schweiz Randstad Vollzeit

    Key Responsibilities: As a Quality Assurance Specialist, you will be responsible for ensuring the high quality of our software products. This includes conducting thorough testing and identifying and reporting any defects or issues. You will work closely with our development team to implement fixes and improve overall quality. Requirements: * 2+ years of...


  • Genf, Genf, Schweiz Randstad Vollzeit

    Randstad is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a key role in maintaining and enhancing the quality assurance processes for critical software, especially in the safety and security domains.Key ResponsibilitiesMaintain the Integrated Management System (IMS) in compliance with...


  • Genf, Genf, Schweiz HSBC Vollzeit

    About HSBC">At HSBC, we are a trusted international organisation with a global customer base of around 39 million customers worldwide through a network that covers 62 countries and territories. Our ambition is to become the leading international wholesale bank in Europe.">Job Summary">We are looking for a Client Quality Assurance and Compliance Specialist to...


  • Genf, Genf, Schweiz Randstad Vollzeit

    About UsRandstad is a leading provider of temporary and permanent staffing services.Job DescriptionWe are currently seeking an experienced Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a key role in maintaining and enhancing the quality assurance processes for critical software, especially in the safety and...


  • Genf, GE, Schweiz Telix Pharmaceuticals (EMEA) Vollzeit

    Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. **At our core, we exist to create products that seek to improve the quality of life for people living with...


  • Genf, Genf, Schweiz Randstad Vollzeit

    We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Quality Department, you will play a crucial role in maintaining and enhancing our quality assurance processes for critical software, focusing on safety and security domains.Key Responsibilities:Maintain our Integrated Management System (IMS) in compliance...


  • Genf, GE, Schweiz Telix Pharmaceuticals (EMEA) Vollzeit

    Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. **At our core, we exist to create products that seek to improve the quality of life for people living with...


  • Genf, Genf, Schweiz Talan Vollzeit

    Job DescriptionAs a Senior Quality Assurance Manager at Talan, you will be responsible for designing and developing comprehensive test strategies aligned with project objectives and timelines. You will execute test plans manually, covering functional, integration, system, and regression testing to identify software bugs and issues. Additionally, you will...


  • Genf, GE, Schweiz Telix Pharmaceuticals (EMEA) Vollzeit

    Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. **At our core, we exist to create products that seek to improve the quality of life for people living with...


  • Genf, Genf, Schweiz randstad - highest Vollzeit

    We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Randstad - Highest. This role will be responsible for maintaining and enhancing the quality assurance processes for critical software, particularly in safety and security domains.As a key member of our Safety, Quality, and Security Manager's team, you will play a crucial...