Director of Quality Assurance
Remote (North Carolina)
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry one patient at a time. To help us achieve our goal, we are seeking a razor-sharp Director of Quality Assurance eager to make an impact within a mission-driven organization.
The Director of Quality Assurance will participate in continuous improvement of the quality system framework at Science 37. This position is responsible for compliance activities at Science 37 including managing the internal audit program, quality management review program, etc. This position is responsible for overseeing vendor selection and qualification of GCP vendors, auditing of vendors, and managing internal and external audits and inspections.
Duties include but are not limited to:
- Oversee the implementation of various continuous improvement initiatives within the company such as Quality Management Review, vendor management, and quality monitoring of clinical trials
- Assisting with the administration of the document management system
- Assisting with the development and refinement of SOPs across the organization
- Overseeing the implementation of the audit management module within the eQMS
- Managing the deviation/CAPA modules
- Administering the vendor qualification and oversight processes
- Overseeing regulatory inspection preparation and the hosting of inspections, including staging room management
- Sponsor audit preparation, hosting and follow-up
- Planning and conducting internal audits of Science 37 operations
- Remaining abreast of current, evolving and new regulations, guidance and industry best practice in clinical trials and research
- Regulatory support and guidance for GCP and CFRs
- Capturing Key Performance Indicators for quality systems and chairing Quality Management Review meetings
- Overseeing equipment validation activities
- Builds an internal culture of innovative thinking that leads to the development and implementation of the company's mission and vision
- Bachelor’s Degree in science, engineering, or another related field required
- 10+ years of experience in quality or compliance in clinical research, biotechnology, or other GxP or regulated environment, or requisite combination of education, training and experience
- Proven track record of cross functional collaboration
- Certification or direct experience in auditing function (e.g. ASQ, etc.)
- Deep knowledge of cGxP regulations and current industry best practices
- Knowledge of 21CFR11 is preferred
- Excellent written and oral communication skills
- Ability to meet deadlines in a fast-paced environment
- Ability to lead cross functional teams to optimize business processes
- Good interpersonal skills
- Strong organizational skills
- Strong creative problem-solving skills, the ability to exercise sound judgment, and make decisions based on accurate and timely analyses
- Ability to provide structure while encouraging innovation
- Ability to tactically implement a strategic vision
- Ability to communicate in English (both verbal and written)
The incumbent reports to the Vice President of Quality and Compliance who will also assign projects, provide general direction and guidance. Incumbent is expected to perform duties and responsibilities with minimal supervision.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
Submit your resume to apply!