Quality Assurance Manager

3 days ago


Reston, Virginia, United States Company Full time
Job Title: Quality Assurance Manager

Company is seeking a highly skilled Quality Assurance Manager to lead and oversee quality assurance activities to ensure compliance with cGMP, GMP, FDA regulations, and GLP standards.

Key Responsibilities:
  • Supervise and mentor a team of quality assurance professionals, including quality control inspectors and analysts.
  • Ensure that all activities comply with cGMP, GMP, FDA regulations, and GLP standards.
  • Investigate and resolve quality issues, non-conformances, and customer complaints.
  • Conduct root cause analysis and implement corrective and preventive actions (CAPAs) as necessary.
  • Prepare and present quality reports, including key performance indicators (KPIs) and trend analyses, to senior management.
Qualifications:
  • Bachelor's degree in a relevant field (e.g., Chemistry, Biology, Engineering) or equivalent experience.
  • Proven experience in a quality assurance role within a regulated industry, preferably with supervisory experience.
  • In-depth knowledge of cGMP, GMP, FDA regulations, and GLP standards.
  • Strong understanding of quality management systems, quality control methodologies, and regulatory compliance requirements.
  • Excellent problem-solving skills and the ability to lead investigations and implement effective CAPAs.
  • Effective communication and interpersonal skills, with the ability to work collaboratively across teams.
Preferred Qualifications:
  • Certification in quality management (e.g., ASQ Certified Quality Engineer or Certified Quality Auditor) is a plus.


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