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Senior Director of Quality Assurance

Green Life Science
New York, NY Full Time
POSTED ON 1/29/2025 CLOSED ON 2/19/2025

What are the responsibilities and job description for the Senior Director of Quality Assurance position at Green Life Science?

Position Summary:


We are seeking a dynamic and experienced Senior Director of Quality Assurance with a speciality in GMP and GLP, to lead and enhance our quality assurance function. This role is ideal for a strategic leader with a proven track record in right-sized GMP & GLP organizations, focusing on phase-appropriate QMS design and implementation. They will ensure that products, services, and processes comply with established quality standards, regulatory requirements, and customer expectations while fostering a culture of continuous improvement. Leading teams in Quality Systems, Quality Operations, and GMP/GLP Audits and Risk Management, this individual will play a crucial role in shaping quality strategy.


Key Responsibilities:


  • Develop and implement comprehensive GMP/GLP quality assurance strategies, policies, and procedures in alignment with the companies goals and industry best practices.
  • Define and monitor key quality metrics and performance indicators to drive continuous quality improvement.
  • Manage and mentor a team of quality assurance professionals, fostering a culture of coaching, development, and professional growth.
  • Analyse quality data to identify trends, root causes of defects, and implement corrective and preventive actions.
  • Provide regular updates on GMP/GLP risks and risk management strategies to senior leadership.
  • Stay informed about regulatory changes and ensure timely updates to quality processes.
  • Work closely with key stakeholders across departments, including Human Subject Research QA, Development, Manufacturing, Regulatory Affairs, and General & Administrative functions, to integrate quality considerations into all aspects of operations.
  • Identify and implement process improvements to enhance product quality, operational efficiency, and overall compliance.
  • Promote a culture of quality through continuous learning, innovation, and feedback mechanisms.


Education & Experience:

  • Bachelor’s degree in Life Sciences or a related field required.
  • Minimum of 15 years of QA experience, including at least 7 years in leadership roles within GMP/GLP organizations.
  • Experience in mid-to-late-stage drug development required.
  • Minimum of 7 years managing direct reports, with preference for experience leading global, cross-cultural teams.


Qualifications & Skills:

  • Expertise in biologics and/or vaccines required.
  • Strong presentation skills with the ability to communicate complex information clearly and concisely.
  • Excellent interpersonal, oral, and written communication skills.
  • Ability to influence, inspire, and drive quality initiatives in a dynamic, growth-oriented environment.
  • Strong project management capabilities.
  • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project).

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