Director of Quality – Contractor

Our client is one of the largest providers of reproductive healthcare drugs.  They have one approved product on the market, and a robust pipeline of women’s health programs in development.  They are seeking a Director of Quality (Contractor) who can ensure that all products meet regulatory and compliance standards. This engagement will be approximately 30+ hours a week for about 3-6 months.  This is a remote role with the potential to become a permanent, full-time employee.


  • Ensure that all products meet regulatory and compliance standards for quality, safety, and efficacy, and that all testing and validation is performed according to industry standards.
  • Develop and implement the Quality Management System, including policies, procedures, and documentation to ensure compliance with regulatory agencies such as the FDA, EMA, and other relevant authorities.
  • Lead and mentor the quality assurance and control teams to ensure that all activities related to product quality are carried out effectively and efficiently.
  • Ensure that the company’s operations run in accordance with their quality policy and goals.
  • Collaborate with other departments, such as Manufacturing, R&D, Regulatory Affairs, and Medical Affairs, to ensure that quality is embedded throughout the product lifecycle.
  • Develop and manage quality metrics and performance indicators to monitor the effectiveness of the Quality Management System and to drive continuous improvement.
  • Stay up-to-date with the latest developments in quality management and regulatory requirements, and ensure that the company’s quality policies and procedures are updated accordingly.
  • Represent the company in interactions with regulatory agencies and other external stakeholders on quality-related matters.



  • Bachelor’s degree in a scientific or engineering discipline. Advanced degree in a related field (e.g., Quality, Regulatory Affairs, or Business) is preferred.
  • At least 10 years of experience in a Quality management role in the pharmaceutical industry, with a strong background in quality assurance and control.
  • In-depth knowledge of relevant regulatory requirements, such as cGMP, GLP, and ISO standards, as well as experience with regulatory submissions.
  • Excellent communication, collaboration, and interpersonal skills, with the ability to build effective relationships with internal and external stakeholders.
  • Strong analytical and problem-solving skills, with a focus on data-driven decision making.
  • Experience with process improvement methodologies, such as Six Sigma or Lean, is preferred.


Note: All contractors must be authorized to work in the United States.  H1B sponsorship is not available.

Apply for this Position

    Your Name*

    Your Email*


    Your Message

    This entry was posted in . Bookmark the permalink.