Principal Quality Systems Compliance Specialist

EyePoint Pharmaceuticals, Inc.-posted about 1 month ago

Full-time • Mid Level

Hybrid • Northbridge, MA

101-250 employees

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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 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 position can be based either at our Northbridge, MA or Watertown, MA site. We offer a hybrid work schedule.

Own the Quality Systems metrics process
Lead and support individuals and teams through root cause analysis investigations
Facilitate investigations into quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
Ability to work collaboratively within Quality Assurance functions to gather information and drive timelines
Generate and monitor metrics (KPI's) for all Quality Operations regarding Quality Management Review
Strong 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 service
Provide 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 leadership
Collaborate cross-functionally with Supply Chain, Manufacturing, Process Engineering, Regulatory and other groups as needed to meet schedule requirements and resolve challenges
Represent 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 initiatives
Support regulatory inspections from a quality system perspective
Manage the Material Review board
Work to further develop and imbue a Quality culture
Contributes to the development and implementation of continuous quality improvement initiatives
Ability to participate in and/or lead risk assessments
Support and/or lead other quality initiatives as needed

Expert knowledge of root cause analysis process with demonstrated ability to utilize common RCA tools
Skilled in technical writing and analytical problem-solving
Must be able to drill down to the true root cause of issues and understand that “human error” is an exception and not the rule
Proficient knowledge of cGMP, with a focus on Drug Product / Combination Product aspects of the MFG process/batch records
Product development process knowledge a plus
Ability to make sound compliance-related decisions with minimal supervision.
Must possess strong attention to detail
Ability to navigate computerized programs such as AssurX (eQMS)
Strong communication (written and verbal) and organizational skills
Ability to independently manage multiple priorities in a dynamic environment
High level of personal/departmental accountability and responsibility
Creatively use business concepts and company policies/procedures to solve problems
Excellent complex problem-solving and teamwork skills
Proficient at resolving issues in creative and innovative ways
Exercises good judgment in selecting methods/techniques to achieve positive results
Presence at both the Watertown and Northridge locations may be required to build relationships with both teams.
Bachelor of Science or a combination of Bachelor degree and industry experience
8+ years’ experience working in a biopharmaceutical/pharmaceutical environment

Preference will be given to someone who has supported quality systems from both a GMP and GCP perspective

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