Director of Quality Assurance

1 month ago

Edison, United States Hartmann Young Full time

Hartmann Young is retained with a company that specialises in the manufacturing and distribution of dietary supplements, vitamins, and related health products. We are working together to hire a Director of Quality Assurance who will lead and manage all aspects of Quality Assurance functions within the company.


The primary focus is ensuring compliance with FDA regulations per 21 CFR 111 and other Federal, State, or local regulations. This role involves managing all aspects of the Quality Management System, from the receipt of raw materials and finished goods to the manufacturing, handling, storage, and distribution of dietary supplements, in accordance with established GMP requirements. Key functions include Product Release activities, Audits, Quality Assurance review and approval, and oversight of the site’s Quality Management system.


Responsibilities;

  • Lead and train QA personnel to ensure compliance with SOPs and cGMP requirements.
  • Develop and manage a Quality Management System (QMS) to enhance plant efficiency and product quality.
  • Serve as the key resource for quality control, problem-solving, and continuous improvement.
  • Establish metrics and systems for monitoring quality and vendor performance.
  • Review customer orders and contracts to ensure quality requirements are met.
  • Interact with customers for quality feedback and improvement opportunities.
  • Oversee facility and product certifications, audits, and regulatory compliance.
  • Manage change control, recalls, product dispositions, and environmental monitoring.
  • Oversee employee training and label approvals, ensuring SOP and cGMP adherence.


Qualifications;

  • BS degree in Biology, Chemistry, or a related science field with 10+ years of experience, or an MS degree with 5+ years of experience in a GMP-regulated Pharmaceutical, Medical Device, Food, or Nutraceutical industry, including 5+ years in a managerial role leading QA/QC teams.
  • Proven track record of business performance improvement.
  • Six Sigma certification/ASQ/PCQI certification is a plus.


Knowledge and skills;

  • Strong interpersonal and written/verbal communication skills.
  • Proven people management and leadership experience.
  • Extensive knowledge of chemical, biochemical, and microbiological concepts.
  • Ability to process complex information and make critical decisions with limited information in a timely manner.
  • Ability to handle multiple competing priorities in a high-growth environment and exhibit responsiveness to shifting priorities.
  • Proficient in using Microsoft Office Applications.
  • Must work at both the "process level" and "organisational level" with cross-functional understanding.


Compensation;

  • Competitive salary and growth within a growing company
  • Healthcare and 401k
  • 20% annual bonus


Think this sounds like you, email me or apply directly for more details.

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