Director, Quality Compliance

EyePoint Pharmaceuticals•Northbridge, MA

6d•Hybrid

About The Position

Be Seen and Heard at EyePoint 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. We See You. Your wellbeing Your professional worth Your future at EyePoint 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. This person will report directly to the Senior Director Global Quality and be responsible for Quality Compliance activities including global inspection readiness (commercial, PAI, BIMO), vendor and supplier management (auditing and oversight), internal auditing and product complaints (both commercial and clinical). This position will requires relationship building/management with partner groups ranging from manufacturing, process development and CMC to clinical affairs (Clinical Operations, Biometrics, medical affairs) and non-clinical. This person will have direct reports. This position will be based at our Northbridge, MA facility, but will be expected to travel at least 1 day per week to our Watertown, MA site. We offer a hybrid work schedule.

Requirements

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
Travel may be required to support vendor/supplier audits where travel is estimated to be up to 10-15%
Experience in multi-GxP areas preferred (GMP, GCP, GLP)
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

Nice To Haves

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

Responsibilities

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.