Senior Quality Director

4 weeks ago


Frederick, Maryland, United States Workforce Genetics Full time

Job Title: Senior Quality Director

We are seeking a highly motivated and dedicated Quality professional to join our team at Workforce Genetics. As a Senior Quality Director, you will be responsible for providing strategic direction and leadership to our Quality Assurance team, fostering a culture of continuous learning and development.

Key Responsibilities:

  • Provide strategic direction and leadership to a top-performing Quality Assurance team.
  • Responsible for the Quality Management System, lot release functions, and operational management of all QA activities.
  • Build external relationships with and oversee management of contract manufacturing organizations.
  • Ensure compliance with relevant regulations and guidelines, including FDA, EMA, and other international regulatory authorities and requirements.
  • Identify and assess quality risks associated with the business and develop risk mitigation strategies.

Requirements:

  • Bachelor's or higher degree with a minimum of 7+ years of cGMP Quality experience.
  • Experience in biologics is a must; cell therapy or ATM experience is a plus.
  • Global Regulatory experience that spans from early-stage to commercial.
  • Strong leadership and people management skills, with the ability to inspire and continuously develop a high-performing team.

About Workforce Genetics:

Workforce Genetics is a leading company in the field of advanced therapy products. We are committed to delivering high-quality products and services to our customers.


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