This is a fully Remote and Work From Home (WFH) opportunity within the US
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. The Science 37 Operating System (OS) enables universal access to patients and providers, leading to faster enrollment, greater retention and a more representative patient population. To help us achieve our goal, we are seeking a Director of Quality and Compliance eager to make an impact within a mission-driven organization.
The Director, Quality and Compliance will participate in the continuous improvement and maturation of Science 37’s global Quality Management System. In collaboration with the VP, Quality and Compliance, this position is responsible for the development of the plans, milestones and tracking of quality-related initiatives in support of organizational goals and objectives including: alignment of the QMS in support of new and evolving Science 37 offerings, global expansion, and merger and acquisition integration. In partnership with subject matter experts across the organization, this position will represent Quality and Compliance in a variety of transformation workstreams in support of their success.
DUTIES AND RESPONSIBILITIES
Duties include but are not limited to:
- Provide subject matter expertise and guidance in foundational quality management systems, including: internal and external audits, vendor qualification, deviations and CAPAs, quality metrics and controlled document management
- Provide subject matter expertise and guidance in the areas of clinical quality assurance (e.g. GCP) and computer systems validation (e.g. 21CFR11/Annex 11)
- Drive a culture of Quality across the organization; measure improvement through the development, monitoring and reporting of metrics
- Develop operational Quality Champions in their role as quality ambassadors; lead Quality Champion meetings hosted by Quality and Compliance
- Support Quality Champions in risk identification, assessment and mitigation as relates to changes or additions to service offerings, globalization, existing process improvement and optimization via trend analysis and feedback channels, both internal and external
- Lead SOP Review Committee meetings, driving the development and refinement of SOPs across the organization
- Continuous optimization of Sponsor audit-related activities to increase efficiency and improve success metrics
- Lead inspection readiness activities across the organization; measure and improve its posture
- Lead RFI support from the QA perspective; coordinate finalization of responses requiring cross-functional input and Quality and Compliance approval
- Develop and maintain Quality and Compliance-related responses for RFIs
- Represent Quality and Compliance in support of business transformation workstreams
- Continued refinement and improvement of the vendor qualification and oversight processes
- Develop, enhance and prepare content; chair Quality Management Review meetings
- Remain abreast of current, evolving and new regulations, guidance, and industry best practice in clinical trials and research
QUALIFICATIONS & SKILLS
- 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
- Deep knowledge of cGxP regulations, 12CFR11/Annex 11 and industry best practices
- Knowledge and ability to contribute in the areas of data privacy, data integrity and data governance
- Excellent organizational and project management skills; able to track and manage complex processes from start to finish
- Analytical and problem-solving skills, with ability to operate at all organization levels
- Strong and effective verbal and written communication skills with the ability to customize approach for a variety of audiences
- A track record of successful cross-functional leadership and delivery through collaboration and effective relationships
- Extraordinary focus on details, analysis and results including ability to work on complex issues with multiple dependencies and stakeholders to drive consensus
- 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.
No direct reports.
Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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!