Chief Compliance Officer
About The Position
At EyePoint , leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our: focus on science and innovation, we aim to offer a lifetime of clearer vision commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases Delivery of innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases. EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.
Requirements
- Experience: Extensive pharma/biotech compliance, legal, or quality experience (10-20+ years), including senior leadership roles.
- Knowledge: Deep understanding of drug/device development, manufacturing (GxP), commercial compliance, data privacy, and US/global regulatory frameworks.
- Leadership: Proven ability to lead, influence cross-functional teams, and drive change in a complex, regulated environment.
- Law degree or strong life science/technical background.
Responsibilities
- Builds and leads healthcare/corporate compliance programs,developing policies, training (GxP, FDA, Fraud/Abuse), and monitoring operations (clinical, commercial) to ensure alignment with evolving regulations (FDA, OIG, Sunshine Act) and internal standards, managing risks, handling investigations, and reporting to leadership while fostering an ethical culture. Key is balancing innovation with strict adherence to global pharma rules and data privacy.
- Program Development: Design, implement, and oversee comprehensive compliance programs, policies, and procedures for R&D, clinical, manufacturing (CMC), and commercial functions.
- Regulatory Expertise: Ensure adherence to global pharma regulations (FDA, EMA), healthcare laws (HIPAA, Fraud & Abuse, Sunshine Act), and GxP (GMP, GCP, GLP), ICH guidelines.
- Training & Culture: Develop and deliver training programs, foster an ethical "speak-up" culture, and set the tone from the top.
- Risk Management: Identify compliance vulnerabilities, conduct audits/monitoring, manage third-party risks, and oversee investigations.
- Strategic Leadership: Serve as a key executive, supporting business development, strategic initiatives, and representing the company with regulatory agencies.
- Reporting: Provide regular reports to senior management and the Board on compliance status and risk.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
