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 success for :
- preventing blindness through vision-saving medications
- delivering best-in-class proprietary pharmaceutical technologies
- transforming ocular drug delivery
We See You.
Your wellbeingYour professional worthYour future at EyePointEyePoint 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 position can be based either at our Northbridge, MA or Watertown, MA site. We offer a hybrid work schedule.
Responsibilities
Primary responsibilities include, but are not limited to, the following :
Individual Responsibilities
Own the Quality Systems metrics processLead and support individuals and teams through root cause analysis investigationsFacilitate investigations into quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectivenessAbility to work collaboratively within Quality Assurance functions to gather information and drive timelinesGenerate and monitor metrics (KPI's) for all Quality Operations regarding Quality Management ReviewStrong technical expertise of QA / QC and Manufacturing processes to support development and maintenance of cGMP compliant quality systems.Reflects solid understanding of strategies, goals and can take part in major parts of projects, or provide expert serviceProvide guidance and support in the development of corrective and preventive actions based on GxP requirements and industry standards.Review and revise relevant policies and procedures to maintain adherence to regulations.Maintain current knowledge of regulations, standards, and guidance documents.Present metrics to area leadershipCollaborate cross-functionally with Supply Chain, Manufacturing, Process Engineering, Regulatory and other groups as needed to meet schedule requirements and resolve challengesRepresent QA in meetings or on project teams, exercising broad authority in decision making and commitments on behalf of QA, elevating only those issues that require buy-in from department Leadership.Lead and / or participate in inspection readiness and process improvement initiativesSupport regulatory inspections from a quality system perspectiveManage the Material Review boardWork to further develop and imbue a Quality cultureContributes to the development and implementation of continuous quality improvement initiativesAbility to participate in and / or lead risk assessmentsSupport and / or lead other quality initiatives as neededQualifications
Primary skills and knowledge required include, but are not limited to the following :
Expert knowledge of root cause analysis process with demonstrated ability to utilize common RCA toolsSkilled in technical writing and analytical problem-solvingMust be able to drill down to the true root cause of issues and understand that “human error” is an exception and not the ruleProficient knowledge of cGMP, with a focus on Drug Product / Combination Product aspects of the MFG process / batch recordsProduct development process knowledge a plusAbility to make sound compliance-related decisions with minimal supervision.Must possess strong attention to detailAbility to navigate computerized programs such as AssurX (eQMS)Strong communication (written and verbal) and organizational skillsAbility to independently manage multiple priorities in a dynamic environmentHigh level of personal / departmental accountability and responsibilityCreatively use business concepts and company policies / procedures to solve problemsExcellent complex problem-solving and teamwork skillsProficient at resolving issues in creative and innovative waysExercises good judgment in selecting methods / techniques to achieve positive resultsOther Requirements :
Presence at both the Watertown and Northridge locations may be required to build relationships with both teams.Preference will be given to someone who has supported quality systems from both a GMP and GCP perspectiveLevel of Education Required :
Bachelor of Science or a combination of Bachelor degree and industry experience
Number of Years of Experience in the Function and in the Industry :
8+ years' experience working in a biopharmaceutical / pharmaceutical environment
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.
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 $124,630.00 / Yr.
Max
USD $157,590.00 / Yr.