Head of Quality

Astrix
Atlanta, GA Full Time
POSTED ON 8/31/2024 CLOSED ON 9/26/2024

What are the responsibilities and job description for the Head of Quality position at Astrix?

Our rapidly growing client is looking for a creative and resilient Head of Quality to join their team! This is a great opportunity to showcase your leadership, quality, and compliance expertise while promoting a quality mentality through the organization.

Location: Atlanta, GA

What’s in it for YOU?

  • Direct hire opportunity
  • Competitive Health and Wellness benefits
  • Financial benefits
  • Great PTO structure

Head of Quality Job Duties:

  • Create, implement, monitor, and maintain quality plans, policies, and objectives.
  • Ensure regulatory standards and requirements are met through quality system management of procedures, personnel, equipment, and product release.
  • Perform internal quality audits and assist in regulatory agency inspections to ensure compliance.
  • Promote, lead, and collaborate across all departments to ensure compliance with GMP and government regulation standards.
  • Identify analytical issues, perform root cause analysis, and remedy deficiencies within departments pertaining to quality issues.
  • Create and monitor tracking metrics to evaluate quality and process improvements.
  • Responsible for final batch record review, product release, and disposition.
  • Responsible for timeliness and final approval for manufacturing investigations.
  • Create and maintain strong relationships with customers to support compliance and enhance quality awareness.
  • Responsible for assessing and negotiating customer Quality Agreements
  • Identify and approve departmental budget, spending, and investments.
  • In charge of staff development, motivation, mentorship, and employee evaluation to ensure Quality within the organization.

Head of Quality Requirements:

  • B.S. or M.S. in Biological Sciences, Engineering, or Operations Management
  • Experience in a VP or Head of Quality role w/ 8 years of leadership experience
  • 15 years of pharmaceutical or biotech industry experience preferred
  • FDA working experience preferred

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