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Head of Quality Management

2 months ago

Edison, New Jersey, United States Hartmann Young Full time

Company Overview:

Hartmann Young collaborates with a leading organization in the production and distribution of health-related products, including dietary supplements and vitamins. We are seeking a Quality Assurance Director to oversee and direct all Quality Assurance operations within the organization.

Key Responsibilities:

  • Lead and mentor Quality Assurance staff to ensure adherence to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
  • Develop and maintain a comprehensive Quality Management System (QMS) aimed at improving operational efficiency and product excellence.
  • Act as the primary resource for quality oversight, problem resolution, and ongoing enhancement initiatives.
  • Establish performance metrics and systems to evaluate quality and vendor effectiveness.
  • Review client orders and agreements to confirm compliance with quality standards.
  • Engage with clients to gather quality feedback and identify areas for improvement.
  • Supervise facility and product certifications, audits, and compliance with regulatory standards.
  • Manage change control processes, product recalls, and environmental monitoring activities.
  • Oversee employee training programs and label approvals, ensuring compliance with SOPs and cGMP.

Qualifications:

  • Bachelor's degree in Biology, Chemistry, or a related scientific discipline with over 10 years of experience, or a Master's degree with a minimum of 5 years in a GMP-regulated environment, including at least 5 years in a leadership role managing QA/QC teams.
  • Demonstrated success in enhancing business performance.
  • Certification in Six Sigma, ASQ, or PCQI is advantageous.

Knowledge and Skills:

  • Excellent interpersonal and written/verbal communication abilities.
  • Proven experience in people management and leadership.
  • In-depth understanding of chemical, biochemical, and microbiological principles.
  • Capability to analyze complex information and make informed decisions promptly.
  • Adept at managing multiple priorities in a dynamic environment while remaining responsive to changing demands.
  • Proficient in Microsoft Office Suite.
  • Ability to operate at both the process and organizational levels with a cross-functional perspective.

Compensation Package:

  • Attractive salary with opportunities for advancement within a growing organization.
  • Comprehensive healthcare benefits and 401k plan.
  • Annual performance-based bonus structure.

This role presents an exciting opportunity to contribute to a thriving company dedicated to quality and excellence in health products.