Director, Quality Assurance

2 weeks ago

Lone Tree, United States VIDA Diagnostics Inc Full time
Join VIDA Diagnostics Inc as a Director, Quality & Regulatory

We 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 quality and innovation in our products and services.

Key Responsibilities:
  • Maintain and improve our quality management system and GCP processes to ensure compliance with regulatory requirements.
  • Develop and execute regulatory strategies that align with business objectives and product roadmaps.
  • Oversee supplier audits, software validation, periodic reviews, QMS/GCP training, CAPA, internal audits, document control, technical writing, and sustainability processes.
  • Participate in risk assessments and develop risk management strategies to mitigate potential hazards associated with SaMD products.
  • Serve as an internal resource for guiding the incorporation of GCP/ISO requirements into SDLC and clinical trial workflows.
  • Facilitate annual internal audits to ensure compliance with customer and regulatory requirements.
  • Serve as the primary point of contact for regulatory agencies, notified bodies, auditing organizations, customers, and other external stakeholders on quality-related matters.
  • Host external audits and inspections.
  • Influence the development of corrective action/preventive action (CAPA) projects to ensure effective issue containment and drive risk-based improvements.
  • Oversee a team of quality, regulatory, sustainability, and data privacy professionals.
  • Monitor and analyze quality performance metrics to identify trends, areas for improvement, and process optimization opportunities.
  • Stay informed about emerging trends, developments, and best practices in quality assurance and regulatory compliance.
  • Create, evolve, approve, and provide feedback on GCP/ISO policies and SOPs.
  • Manage and ensure adherence to the department budget.
  • Maintain company ISO certifications and regulatory registrations.
Requirements:
  • Bachelor's degree in computer science, health science, biomedical engineering, or a related field.
  • Advance degree and one or more certifications in regulatory affairs, quality management, and CCRP are preferred.
  • 10+ years of progressive experience in quality assurance and/or regulatory affairs in a highly regulated environment.
  • 5+ years in a leadership role overseeing, coaching, and mentoring high-performing teams.
  • In-depth knowledge of and experience with ICH E6, FDA's Clinical Trial Imaging Endpoint Process Standards Guidance for Industry, Part 11, EMA Guideline on computerized systems and electronic data in clinical trials, FDA QSR, ISO 13485, IEC 62304, and ISO 14971.
  • Strong understanding of software development lifecycle (SDLC) methodologies and agile principles.
  • Excellent leadership, negotiation, and communication skills.
  • Demonstrative problem-solving abilities and a proactive, results-oriented mindset.
Preferred Qualifications:
  • Prior experience with SaMD products or digital health technologies is highly desirable.

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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