Apply on Employer Site

EyePoint · 1 day ago

Director, Quality Compliance

Northbridge, MA

Full-time

Hybrid

Director/Executive

$194K/yr - $244K/yr

15+ years exp

EyePoint is an ophthalmology company committed to improving the lives of patients with serious retinal diseases through innovative therapeutics. The Director of Quality Compliance will manage the Quality Compliance team, ensure compliance with global regulatory expectations, and lead harmonization initiatives across GxP functions while fostering a culture of continuous improvement.

BiotechnologyHealth CareMedicalPharmaceutical

Responsibilities

Primary responsibility will be to manage the Quality Compliance team and lead harmonization initiatives to globalize quality compliance processes across GxP functions

Partner with other Quality Assurance functional leads to ensure compliance all functions is met

Help to 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 within respective areas

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.) supporting R&D, clinical affairs and technical operations

Oversee external vendor oversight process (e.g., Qualification/Requalification, Quality Agreements, Periodic Review, Approved Vendor/Supplier List Maintenance, SCARs)

Perform regulatory surveillance of vendors/suppliers

Oversee and enhance internal audit program

Ability to 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 (e.g., FDA BIMO, PAI, routine) to include hosting plan, front/backroom process and SME preparation for multiple locations (global)

Represent Quality Compliance during regulatory inspections

Notify/escalate to Quality Sr. Management potential quality compliance concerns

Performs other duties as assigned

Qualification

Quality ComplianceGxP leadershipRegulatory guidelines interpretationVendor managementInternal auditingCustomer service approachCollaboration skillsCommunication skillsAttention to detailTeam player

Required

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 and 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 that has a customer service approach and is solution oriented

Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and suppliers

Bachelors or advanced degree in 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

Preferred

Experience in multi-GxP areas preferred (GMP, GCP, GLP)

Company

EyePoint

EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of people with serious retinal diseases.

Founded in 1987

Watertown, Massachusetts, USA

51-200 employees