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Director of Quality Assurance

2 months ago

Miami, United States Albion Rye Associates Full time

Job Title: Director Quality Assurance

Location: Miami


We are working with a cell and gene therapy company committed to developing innovative treatments to address unmet medical needs. We are looking for a Director of Quality Assurance to join the team. This position will play a critical role in establishing and maintaining a robust Quality Assurance strategy and Quality Management System (QMS). You will ensure that all activities comply with global quality requirements and regulatory standards, supporting their commitment to delivering high-quality cell and gene therapy products.


Key Responsibilities:

  • Establish a comprehensive quality strategy aligned with the company's vision and regulatory requirements.
  • Lead the development, implementation, and continuous improvement of quality policies, procedures, and systems.
  • Implement and manage a Quality System that complies with all applicable global quality standards, including FDA, EMA, and other regulatory bodies.
  • Ensure the Quality System supports efficient and compliant manufacturing and product release processes.
  • Ensure compliance with all relevant regulatory requirements, guidelines, and industry best practices.
  • Prepare for and manage regulatory inspections and audits, including FDA, EMA, and other regulatory agencies.
  • Oversee the preparation and submission of regulatory documentation related to quality.
  • Oversee all quality operations, including QA oversight of manufacturing, quality control, and supplier quality.
  • Implement and monitor key quality metrics and performance indicators to drive continuous improvement.
  • Lead investigations and resolution of quality issues, including deviations, CAPAs, and complaints.
  • Lead and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.
  • Collaborate with cross-functional teams, including Manufacturing, R&D, Regulatory Affairs, and Supply Chain, to ensure alignment and integration of quality processes.
  • Provide quality-related training and education to staff to promote a quality-focused mindset across the organization.
  • Develop and implement risk management strategies to identify, assess, and mitigate quality risks.
  • Ensure robust change control processes are in place to manage changes impacting product quality.


Qualifications:

  • Bachelor's degree in a scientific discipline; advanced degree preferred.
  • Minimum of 10 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry, with a focus on cell and gene therapy.
  • Extensive knowledge of global quality regulations and standards (e.g., FDA, EMA).
  • Proven experience in developing and managing a Quality System in a regulated environment.
  • Strong leadership skills with the ability to influence and drive change.
  • Excellent problem-solving, analytical, and decision-making abilities.
  • Effective communication and interpersonal skills to work collaboratively with cross-functional teams.
  • Ability to manage multiple priorities and projects in a fast-paced, dynamic environment.