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?
Location: Atlanta, GA
What’s in it for YOU?
- Direct hire opportunity
- Competitive Health and Wellness benefits
- Financial benefits
- Great PTO structure
- 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.
- 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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