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QA Operations Manager (FULLY ONSITE)

QA Operations Manager (FULLY ONSITE)

Thermo Fisher ScientificHigh Point, North Carolina, United States of America
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  • Aide in the release of products by resolving CAPA, Change Management, and deviation / OOS compliance issues.
  • Support the plant during regulatory inspections.
  • Ensure the Quality Management System (QMS) is followed at High Point through SOP operational adherence.
  • Leads and manages the DEA program for the site.
  • Lead cross-functional teams in quality / compliance improvement activities.
  • Serve as the primary technical subject matter expert for troubleshooting, problem-solving, and operational quality assurance.
  • Ability to apply sophisticated technical and organizational problem-solving methodologies.
  • Identify negative quality / compliance trends and determine root causes for correction. Assist in assigning appropriate corrective and preventative actions.
  • Maintain up-to-date knowledge of global regulations and quality standards.
  • Review and approve various operational documentation requiring QA oversight.
  • Drive the implementation and improvement of global and regulatory policies and procedures to meet regulatory and customer expectations.
  • Establish collaborative relationships with operations and support group leaders.
  • Manage and develop Quality Assurance Engineers and Data Review teams.

    • Qualifications

    • BS degree with 6-8 years of GMP experience within the pharmaceutical or medical device industries.
    • Proven ability to independently prioritize multiple projects.
    • Excellent communication skills for presenting information to senior management and public groups.
    • Advanced proficiency in statistical analysis and problem-solving tools.
    • Ability to meet DEA security clearance requirements.

      • We value your experience and perspective, and together we will successfully implement strategies that maintain our competitive edge.

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    Operation Manager • High Point, North Carolina, United States of America