Director, Quality Assurance
2 weeks ago
We are seeking a highly skilled and experienced Director, Quality & Regulatory to lead our quality management system and regulatory affairs efforts. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:- Maintain and improve our quality management system and GCP processes in accordance with regulatory requirements.
- Ensure all clinical trials supported by VIDA comply with regulatory requirements and industry standards.
- Develop and execute regulatory strategies that align with business objectives.
- Oversee supplier audits, software validation, periodic reviews, and other quality-related processes.
- Participate in risk assessments and develop risk management strategies.
- Facilitate internal audits and serve as the primary point of contact for regulatory agencies and external stakeholders.
- Host external audits and inspections.
- Oversee a team of quality, regulatory, and data privacy professionals.
- Monitor and analyze quality performance metrics.
- Stay informed about emerging trends and best practices in quality assurance and regulatory compliance.
- Bachelor's degree in a relevant field.
- 10+ years of experience in quality assurance and/or regulatory affairs in a highly regulated environment.
- 5+ years in a leadership role overseeing high-performing teams.
- In-depth knowledge of ICH E6, FDA QSR, ISO 13485, and other relevant regulations.
- Strong leadership, negotiation, and communication skills.
- Prior experience with SaMD products or digital health technologies.
VIDA Diagnostics Inc is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veterans status, age, or disability.
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Director, Quality Assurance
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Lone Tree, United States VIDA Diagnostics Inc Full timeJoin VIDA Diagnostics Inc as a Director, Quality & RegulatoryWe are seeking a highly experienced and skilled Director, Quality & Regulatory to lead our quality management system and regulatory affairs efforts. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and industry standards.Key...
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Director, Quality Assurance
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Lone Tree, United States VIDA Diagnostics Inc Full timeJoin VIDA Diagnostics Inc as a Director, Quality & RegulatoryWe are seeking a highly experienced and skilled Director, Quality & Regulatory to lead our quality management system and regulatory affairs efforts. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and industry standards, while driving...
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