Quality Manager

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in
  

• Ensure compliance with all federal, state, and local regulatory requirements, including
  

• Lead and manage internal and external audits, regulatory inspections, and customer
  

• Conduct risk assessments and implement corrective and preventive actions (CAPAs)
  

• Oversee the documentation control system, including SOPs, change controls,
  

• Develop and deliver training programs on quality and compliance topics for
  

• Manage product complaints, returns, recalls, and investigations.
• Collaborate with warehouse and operations teams to ensure adherence to product
  

• Monitor quality metrics and generate reports for senior management.
• Review and approve batch documentation, temperature excursion reports, and
  

• Maintain current knowledge of industry regulations and standards and provide
  

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field required.
  

Experience

• 8+ years of experience in quality assurance within pharmaceutical, biotech, or
  

• Knowledge of FDA regulations, GDP, cGMP, and other applicable quality standards.
• Experience with regulatory inspections and compliance audits.
• Experience with controlled substances handling is a plus.
  

Working Conditions

• Primarily office-based with monthly/quarterly visits to branches.
• May require occasional travel for audits, inspections, or training.