Director, Quality Compliance

About Eye Point

EyePoint is a patient‑centric, award‑winning ophthalmology company committed to improving the lives of patients with serious retinal diseases by developing and commercializing innovative therapeutics.

This Director role reports directly to the Senior Director Global Quality and is responsible for Quality Compliance activities including global inspection readiness (commercial, PAI, BIMO), vendor and supplier management, internal auditing and product complaints across commercial and clinical programs. The position is based at our Northbridge, MA facility with expected travel to Watertown, MA and a hybrid work schedule.

• Lead the Quality Compliance team and drive harmonization initiatives to globalize quality compliance processes across GxP functions.
• Define clear Quality Compliance objectives and ensure progress and cross‑functional completion of responsibilities.
• 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 processes (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 post‑market reporting requirements.
• Lead and/or participate in inspection readiness efforts across GxP functions, including hosting plan, front/backroom 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 personality, 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 for 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, with estimated travel 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.

EyePoint is proud to be an equal‑opportunity employer. All applicants will be considered for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.