Directeur académique de la restauration chargé de moderniser l’offre pour le Crous de Nice - Toulon. Supervisant l’activité restauration universitaire et garantissant la sécurité sanitaire.
About the role
- Director of Quality ensuring Visby’s products meet highest standards of quality and compliance. Leading a team in a biotech startup to drive continuous improvement throughout product lifecycle.
Responsibilities
- Maintain a robust and effective QMS that is compliant with relevant regulations (e.g., FDA QSR, ISO 13485) and consensus standards.
- Serve as the company’s management representative by reporting to top management on the effectiveness of the QMS and the need for any improvements.
- Ensuring promotion and awareness of the QMS and of applicable regulatory requirements.
- Actively participate in the day-to-day QMS activities and develop an in-depth knowledge of the drivers of product quality.
- Stay abreast of changes to relevant quality system regulations and consensus standards and ensure that Visby’s QMS is appropriately updated.
- Collaborate with supply chain and subject matter experts to ensure the quality and reliability of suppliers and contractor manufacturers though the use of supplier controls.
- Ensure that effective supplier quality agreements are developed and implemented with suppliers and contractor manufacturers, including those located outside the United States.
- Ensure that risk management activities are effectively used to drive improvement to product quality throughout the product life cycle.
- Oversee software quality assurance, including software verification activities and collaborating with stakeholders to ensure implementation of cybersecurity requirements.
- Oversee an efficient and effective document control system.
- Ensure that quality audits are planned, conducted and that effective corrective actions are taken when needed.
- Serve as the company point of contact with external quality system auditors (e.g., FDA).
- Ensure effective quality system training and establish metrics to monitor training effectiveness.
- Ensure efficient and effective quality control processes and procedures, including use of appropriate sampling techniques.
- Foster a culture of quality throughout the organization by promoting awareness, accountability and continuous improvement.
Requirements
- A bachelor’s degree in engineering, life science or a related field, an advanced degree preferred.
- A minimum of 5+ years of quality system management experience, preferably in in vitro diagnostics.
- In-depth knowledge of relevant regulations and standards (e.g., FDA QSMR, ISO 13485)
- Demonstrated ability to effectively manage supplier quality.
- Experience with technology transfer and process validation in remote or outsourced manufacturing environments.
- Willingness to travel internationally as needed to support supply quality.
- Strong understanding of risk management principles and practices.
- Proven ability to work with a cross-functional team.
Benefits
- highly competitive health insurance through United Healthcare or Kaiser
- company-funded HSA option
- flexible paid time off
- 10 company holidays
- many other contemporary benefits and perks
Job title
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Degree requirement
Tech skills
Location requirements
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