Be Seen and Heard at EyePoint Pharmaceuticals

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 success for:

• developing therapeutics to improve the lives of patients with serious retinal disease
• advancing best-in-class proprietary drug delivery technologies
• innovative pipeline of sustained delivery products

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 VP, Quality and be responsible for the Clinical Quality activities including responsible for creating/monitoring and maintaining phase appropriate ICH levels of compliance in all of our CROs, as well as within EyePoint. The scope of this role includes working with Clinical Development / Operations and CROs on the review / approval of clinical activities and associated documentation.

This position is located at our Watertown, MA facility. We offer a hybrid work schedule.

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

This position will be dedicated to supporting our early and late-stage assets. The Associate Director/Senior Manager of Clinical Quality will develop, manage, and improve existing quality systems to ensure appropriate controls for EyePoint in-house GCP and GLP capabilities. This includes the expansion of existing Clinical Quality Management System (QMS), development of documents, training of personnel, and quality oversight of clinical development. This position will be responsible for QA aspects of supplier (i.e. CROs) oversight including audits, establishment of Quality Agreements, and major deviation review. This position will be responsible for BioResearch Monitoring Program (BIMO) inspection readiness, as well as QA support of post approval pharmacovigilance systems.  Works directly with EyePoint Clinical Operations, Development and Pharmacovigilance departments to provide continual oversight to enforce requirements and meet guidelines.

Primary responsibility will be to develop and administer the GLP/GCP global quality system, SOPs and training to ensure organizational compliance with regulatory requirements.  This person will have overall responsibility to assure initiatives related to clinical quality and compliance are optimized and executed appropriately. 

• Define and drive the Clinical quality and compliance vision and mindset of the entire company in close collaboration with the executive leadership team.
• Define clear CQA objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions, and drive risk analysis and mitigation strategies.
• Provide Quality Assurance oversight, compliance support and be the QA represent for EyePoint Clinical Development Teams.
• Ensure appropriate quality systems are in place to audit CROs and suppliers, clinical sites, regulatory documents, and to validate clinical and regulatory systems/software and databases.
• Provide GCP Auditing including audit preparation, execution of the audit, the audit report, and follow up to any finding(s).
• Ensure appropriate systems are in place for follow-up and closing investigations and audit observations.
• Ensure that exceptions are analyzed for corrective and preventive actions (CAPAs).
• Oversee all aspects of Quality related to execution of clinical studies.
• Prepare for FDA/Health Authority inspections of EyePoint or clinical sites.
• Provide leadership, guidance, and direction to staff consistent with GCP.
• Participate in initiatives related to critical quality processes such as essential document management, data management, trial management, investigational product management, etc.
• Partner with the Clinical teams to write, revise, and approve appropriate SOPs, Work Instructions and Forms
• Ensures adherence to GCP requirements and SOPs including training plans and training.
• Takes lead role in organizing and completing investigations, coordinates with other departments involved, and drives closure in a timely manner.
• Provide routine communication to the Senior Leadership Team about the overall status of the Quality Management System.

Primary skills and knowledge required include, but are not limited to the following:

• Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.
• Experience interacting with regulatory health authorities at pre- and post-approval inspection.
• Established expertise and training in GCP/GLP systems.
• Experience with FDA, ICH and EMEA guidelines and regulations.
• Ability to evaluate Quality Systems 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.

Other Requirements:

Domestic Travel will be required to facilitate robust partnerships and execution.
Depending on growth of organization and the primary work location, travel is estimated to be up to 20%

Level of Education Required:

• Bachelors or Advanced degree in a scientific discipline.

Number of Years of Experience in the Function and in the Industry:

• Minimum 6+ years’ experience in the pharmaceutical/biotech industry/CRO
• 3+ years of CQA leadership experience, with a successful track record in managing CROs as well as leading all internal CQA duties

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

• Success begins with our People
• Patients First
• Integrity
• Results-Driven
• Innovation
• Team Focus
• Diversity & Inclusion

EyePoint Pharmaceuticals 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.

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