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.
Responsibilities:
- 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.
Qualifications:
- 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.