Science 37, a GV & Glynn Capital funded life sciences company, is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. We are seeking a razor-sharp VP of Quality and Compliance eager to make an impact within a mission-driven organization changing the world through clinical research.
The Vice President of Quality and Compliance is a key member of the organization who assumes a leadership role in the overall quality and compliance matters. This position is responsible for all quality related activities including quality assurance, quality control, and compliance. The VP, Quality and Compliance is expected to develop and successfully execute quality and compliance strategies to ensure corporate objectives are met within applicable regulations and guidelines.
Duties include but are not limited to:
- Serve as a key and active member of the leadership team, interacting with team members to ensure objectives are aligned and that the company is performing to operational objectives
- Responsible for all Quality related activities including quality assurance, quality control, and compliance
- Sets strategic programs for implementing phase appropriate quality standards and practices
- Responsible for supplier qualification audit and inspection management,
- Perform tactical duties such as product disposition (if required), vendor audit and management, document management, deviation, and CAPA management
- Provide management and leadership with regard to quality and compliance
- Counsel, train and interpret regulatory requirements to ensure company is in compliance at all times
- Oversee preparations and filing of documents for all sponsor visits
- Develop and maintain external relationships with reg
- Develop and maintain systems, practices, and processes to ensure quality and compliance
- Provider leadership and directions for significant deviations events that may impact compliance status or significant business risk
- Develop and successfully execute compliance strategies and implementation plans to ensure corporate objectives are met within applicable regulations and guidelines
- Direct the development of systems, practices, and processes to ensure efficient and effective clinical trials including clinical trial management and data analysis, while ensuring all clinical studies operate to the highest ethical and safety standards
- Remain informed of competitive regulatory and clinical practices and utilize knowledge in the development and adjustment of company plans
- Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization
- Provide leadership support, training and guidance to all company personnel with regards to quality and compliance
- Responsible for ensuring company’s compliance with all regulatory agencies and all applicable standards worldwide
- Oversees, manages and builds the Quality and Compliance team.
- Conducts performance reviews, calibration sessions, and feedback discussions with direct reports in a timely, frequent, and in a direct manner that is consistent with the company-wide keystone focus.
- Performs competency assessments across their team and implements and monitors development plans with direct
- Mentors and/or assists in coaching and training direct reports.
- Builds an internal culture of innovative thinking that leads to the development and implementation of the company's mission and
- Bachelor’s Degree required
- 10+ years of experience in quality, regulatory and compliance affairs
- In-depth knowledge of and experience with ICH-GCP and research-applicable CFRs (e.g. 21CFR312, 21CFR812, 21CFR11)
- Proven track record of leadership and management of quality and compliance
- Extensive knowledge of regulations and compliance requirements
- Effective communicator: high level, written and oral communication skills; strong communication, negotiation and influence skills
- Extensive management and team leadership experience; successful at managing people/projects
- Strong leadership and execution skills; proven track record of delivering results and meeting targets
Skills and Competencies
- Strong interpersonal skills, ability to communicate and manage well at all levels of the organization
- High level of integrity and dependability with a strong sense of urgency and results-orientation
- Ability to foster and cultivate business opportunities and partnerships
- Strong analytical skills and experience interpreting a strategic vision into an operational model
- Communicates and exhibits leadership behavior consistent with the company-wide keystone focus.
- Experience in building and guiding organizational Leverages each team member's unique background and perspective to achieve team goals while providing clear direction and accountabilities. Commitment to collaboration, within and across departments.
- Understands interpersonal and group dynamics and reacts in an effective and tactful manner and has a range of interpersonal skills and approaches with ability to select a best-fit
- Ability to motivate, influence and guide team members and direct reports; gains commitments from
- Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed
- Ability to communicate in English (both verbal and written)
The position reports to the Chief Operating Officer.
- Director, Computer Quality Assurance
- Director of Compliance
- Manager, Clinical Quality Assurance
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!