ProClinical is seeking a Validation Lead for a leading medical device company, to be based in Switzerland on a permanent basis.
- Take ownership and oversee the design, development, verification and validation of molecular based assays in support of pre-clinical and clinical trials.
- Develop and sustain the V&V skill portfolio supporting R&D strategy and business needs
- Create and review documents and reports, develop release testing methods and acceptance criteria, transfer new products to operations and participate in development activities necessary for world-wide regulatory clearance and launch of new products.
- Supervises assigned staff. Ensures that the incumbent and staff have received appropriate training and that the training is current. Provide work assignments to direct reports on a regular basis. Review and approve the work performed by other analysts. Ensure work is done in a compliant manner according to SOPs and GLP guidelines.
- Establish and enhance SOP, implementation and training of new procedures and processes
- Collaborate as necessary with other departments including project management, Quality & Regulatory Affairs and external suppliers
- Present scientific findings and developed technologies in meetings and publish relevant articles in scientific journals.
- Willingness to travel worldwide.
Skills and Requirements:
- Several years of professional experience in the areas of product development and verification & validation of IVDs.
- Molecular biology background with in-depth knowledge of DNA detection methodologies.
- Experience leading and managing cross networked teams, is considered a strong asset.
- Experience in the regulated medical environment (IVDD, EN ISO 13485) and laboratory and test automation.
- Knowledge in Design of Experiment and applied statistics.
- Experience working in a start-up environment.
- Proactive forward thinker who leads by doing, assertive in nature with strong communication skills to match.
- Ability to manage and lead small teams.
- Excellent command of English and can write in a clear and concise fashion.
- Drive and passion to develop new in vitro diagnostic products that improve patients' lives
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Herman Baer on + 41 78 679 7787 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
ProClinical is advertising a vacancy for an Operations Regulatory CMC Analyst
ProClinical is advertising a vacancy for a Drug Safety Manager
ProClinical is advertising a vacancy for a Regulatory Affairs Manager
ProClinical is advertising a vacancy for a Quality Compliance Specialist III position
ProClinical is advertising a vacancy for a Quality Assurance Specialist III position
ProClinical is advertising a vacancy for a Brand Insights Manager vacancy
ProClinical is advertising a vacancy for a Solution Engineer vacancy
ProClinical is advertising a vacancy for a Senior Research Associate - Fibrosis
Foster City, California
ProClinical is advertising a vacancy for an Associate Scientist - Fibrosis position
ProClinical is advertising a vacancy for an In-Vitro Scientist in Liver Toxicity
ProClinical is advertising a vacancy for a Clinical Quality Oversight Lead vacancy