Director, Quality Compliance

Director, Quality Compliance – Eye Point

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At Eye Point , we aim to offer a lifetime of clearer vision by developing and commercializing innovative therapeutics for serious retinal diseases. Leadership trusts employees to get the job done in a patient‑centric, award‑winning environment.

• Lead the Quality Compliance team and drive harmonization initiatives to globalize quality compliance processes across GxP functions.
• Partner with Quality Assurance functional leads to ensure compliance across all functions.
• Define clear Quality Compliance objectives and ensure progress and cross‑functional completion.
• Provide leadership, guidance, and direction to staff consistent with GxP guidance.
• Foster an environment that supports compliance and drives continuous improvement activities.
• Own vendor and supplier management quality program across clinical and commercial programs, ensuring alignment with global regulatory expectations (FDA, EMA, ICH, etc.).
• Oversee external vendor oversight process (qualification/requalification, quality agreements, periodic review, approved vendor/supplier list maintenance, SCARs).
• Perform regulatory surveillance of vendors/suppliers.
• Oversee and enhance internal audit program; conduct external and internal audits as needed.
• Oversee and scale up global processes for product quality complaints, field alert reporting, investigation closure, and compliance with post‑market reporting requirements.
• Lead and/or participate in inspection readiness efforts across GxP functions to include hosting plan, front/back room process and SME preparation for multiple locations (global).
• Represent Quality Compliance during regulatory inspections.
• Notify/escalate potential quality compliance concerns to Quality Senior Management.
• Perform other duties as assigned.

• Strong collaboration and influencing skills across diverse functions and levels of the organization.
• Excellent verbal and written communication skills, detail‑oriented, and ability to work and drive change across functions.
• Expert at interpreting guidelines and regulations (FDA, ICH, EMEA, etc.).
• Experience interacting with regulatory health authorities at pre‑ and post‑approval inspections.
• Ability to evaluate quality programs and drive value‑added enhancements.
• Strong team player with a customer‑service approach and solution orientation.
• Attention to detail and ability to work individually, within a multidisciplinary team, and with external partners and suppliers.

• Travel may be required to support vendor/supplier audits (up to 10‑15%).
• Experience in multi‑GxP areas preferred (GMP, GCP, GLP).

Bachelor’s or advanced degree in a scientific discipline.

• Minimum 15+ years’ experience in the pharmaceutical/biotech industry.
• 3+ years of GxP leadership experience with a successful track record in managing internal teams.

USD $‑$ per year.

Full‑time.

Northbridge, MA – hybrid schedule; expected to travel at least 1 day per week to Watertown, MA.

Robust total rewards in a science‑based entrepreneurial culture that empowers curiosity and innovation.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.