Our client is one of the largest providers of reproductive healthcare drugs. They have one approved product and a robust pipeline of women’s health programs in development. They are seeking a Regulatory & Quality Systems Contractor who can help establish and manage regulatory and quality systems for the company. In this role you will participate in interactions with vendors, manage documentation, and ensure company compliance. This engagement will be approximately 40 hours a week for about 3-6 months. This is a remote role.
Responsibilities:
- Lead development, enhancement, management and assurance of quality and documentation systems for external and internal operations, including GMP drug and device development, regulatory, manufacturing, distribution, REMS, clinical and other activities.
- Develop and execute quality strategies for operational, manufacturing, clinical and nonclinical activities.
- Lead complaint / CAPA investigations, documentation and execution.
- Lead and manage quality systems training as internal assessments.
- Provide quality systems input for all development, manufacturing and other activities, including review or authoring of essential and supportive documents.
- Coordinate and consult with other team members on other quality activities, including reviews and audits.
- Ensure consistency, completeness, and adherence to standards for all quality documents.
- Keep senior regulatory/quality management informed and advised of all key assurance issues. Develop, monitor and report on quality performance indicators, product quality reviews and trend analysis.
Qualifications:
- A Bachelor’s degree in life sciences.
- 5+ years of regulatory and quality operations, documentation, and systems experience.
- Demonstrated track record of leadership, expertise and hands-on execution of quality systems and assurance in small-medium pharmaceutical company.
- Background in quality and regulatory systems and operations for drug development and other quality areas.
- Ability to effectively anticipate, prevent, and solve challenges.
- Outstanding communication, analytical, and organizational skills
- Excellent project management skills, with the ability to manage multiple projects and prioritize appropriately.
- Ability to prioritize multiple urgent priorities and experience with wearing multiple hats.
- Strong interpersonal and agency management skills.
Note: All contractors must be authorized to work in the United States. H1B sponsorship is not available.