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 seeking a razor-sharp Director of Compliance eager to make an impact within a mission-driven organization. As part of the Science 37 team, you will be responsible for compliance activities at Science 37 including managing the internal audit program, quality management review program etc. Also, this position is responsible for overseeing vendor selection and qualification of GCP vendors, auditing of vendors, managing external audits and inspections. Interested? Keep Reading!

Duties and Responsibilities 

• Participate in the implementation of various continuous improvement initiatives within the company such as Quality Management Review, vendor management, and quality monitoring of clinical trials
• Responsible for the administration of the document management system
• Support the development and refinement of SOPs governing quality and compliance
• Assist with the implementation of the electronic audit management system within the quality management system
• Identify new regulations and guidance; preparing white papers and compliance initiatives
• Oversee equipment validation activities
• Help administer the deviation/CAPA system
• Administer the vendor management system
• Participate in regulatory inspection preparations, and the execution of inspections, including running the “war room”
• Participate in sponsor audits
• Conduct and participate in internal audits of Science 37 operations
• Remain abreast of current regulations and industry best practices in clinical trials and research
• Capture KPI's for quality systems and participate in Quality Management Reviews

Qualifications

• 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 experience in auditing function (e.g. ASQ etc.)
• Knowledge of cGXP regulations and current industry best practices
• Excellent written and oral communication skills
• Experience leading cross functional teams to improve business processes

Skills/Competencies

• Excellent 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 deliver information in a rational manner
• Ability to meet deadlines in a fast-paced environment
• Strong analytical skills 

 Capabilities

• Ability to communicate in English (both verbal and written)

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Enjoy daily healthy catered lunches, snacks and beverages, and top-notch equipment such as the latest Macbook Pro, 4k monitors, and adjustable standing desks. Submit your resume to apply!