Director, Quality Compliance

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.

Responsibilities

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

Individual 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.

Qualifications

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

• 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

Other Requirements:

• 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)

Level of Education Required:

Bachelors or advanced degree in scientific discipline.

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

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

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to improving the lives of patients with serious retinal diseases by developing and commercializing innovative therapeutics.

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

Transformational Innovation

We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

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.

EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.

The target salary range for this position is listed below.

#LI-Hybrid

Min

USD $193,640.00/Yr.

Max

USD $244,453.00/Yr.