Senior Quality Assurance Manager

4 weeks ago


Detroit, Michigan, United States Thor Companies Full time

The Senior Quality Assurance Manager at Thor Companies is responsible for ensuring the integrity of pharmaceutical products by maintaining compliance with cGMP regulations and industry standards. This role drives Quality Operations Procedures and works closely with stakeholders to align Quality Systems with Operations and Supply Chain. The ideal candidate will ensure adherence to Global Quality Standards, adapt to regulatory changes, and promote best practices across locations.

  • Establish effective communication networks among plant personnel, management, staff, and regulators.
  • Manage staffing, training, motivation, and team communication.
  • Develop and execute departmental objectives aligned with site goals.
  • Make all site-related quality decisions.
  • Lead management review meetings and contribute to GXP-compliant Quality Operations Policies.
  • Support the implementation of Quality Operations Policies.
  • Host regulatory inspections and address inquiries.
  • Monitor compliance in manufacturing and packaging processes.
  • Stay current on regulations and Good Manufacturing Practices.
  • Ensure adherence to quality manufacturing standards and prepare facilities for audits.
  • Act as Management Representative, overseeing the effectiveness of the quality system.
  • Support Compliance Intelligence to identify and respond to global trends.

Requirements

  • Bachelor's Degree in Chemistry or a related science required; advanced degree preferred.
  • 15+ years in Quality Assurance/Compliance within the pharmaceutical or biotech industry.
  • Proven experience leading FDA inspections.
  • Deep understanding of global GXP requirements.
  • Strong knowledge of pharmaceutical manufacturing processes.
  • Proficient in laboratory testing procedures and instruments.
  • Experienced in FDA inspection techniques.


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