Associate Director, Quality Assurance Auditing

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 an Associate Director, Quality Assurance Auditing eager to make an impact within a mission-driven organization. 

POSITION OVERVIEW

The Associate Director, Quality Assurance Auditing will represent Science 37 Quality and Compliance’s key interests with regard to quality management including, but not limited to: conducting and reporting GxP audits, ongoing quality document development and management, investigation and resolution of quality concerns, and KPI development and monitoring, as applicable.  

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to:

1. Prepares, conducts, reports on and supports conclusion of audits and associated observations in all of the following categories: GCP, GLP, GMP and CSV
2. In partnership with operational functions and other stakeholders, assesses the need for quality-related KPI definition, implementation and monitoring
3. Liaises with the head of Procurement and or their designee(s) on topics of mutual interest including, but not limited to: results of periodic vendor assessments, vendor quality metrics, and vendor quality or performance concerns
4. Oversees Sponsor Quality Management Agreements under which Science 37 is the vendor; ensures the fulfillment of the necessary requirements such as notifications, KPIs and governance-related activities
5. Supports the development, review and ongoing processing of Science 37 quality documentation
6. Supports and/or hosts client audits and regulatory inspections, if required
7. Remains abreast of current, evolving and new regulations, guidance, and industry best practice
8. Management and/or mentorship of junior level staff as they are on-boarded into the department

QUALIFICATIONS & SKILLS

Qualifications 

**GCP and CSV Auditing required and GLP/GMP familiarity preferred**

1. Bachelor’s Degree in science, engineering, or another related field required or 6+ 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
2. Knowledge of cGxP regulations, CSV process and industry best practices

Skills/Competencies

1. Excellent organizational and project management skills; able to track and manage complex processes from start to finish
2. Analytical and problem-solving skills, with ability to operate at all organization levels
3. Strong and effective verbal and written communication skills with the ability to customize approach for a variety of audiences 
4. A track record of successful cross-functional leadership and delivery through collaboration and effective relationships
5. Extraordinary focus on details, analysis and results including ability to work on complex issues with multiple dependencies and stakeholders to drive consensus
6. Ability to tactically implement a strategic vision

Capabilities

Ability to communicate in English (both verbal and written)

Primarily domestic travel required up to 60%; international travel potential <10%

REPORTING

The position reports to the Director of Quality and Compliance 

DIRECT REPORTS

No current direct reports however line management could be a possibility.

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!