Principal Quality Systems Compliance Specialist

Principal Quality Systems Compliance Specialist

Join to apply for the Principal Quality Systems Compliance Specialist role at Bio Space
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Be Seen and Heard at Eye Point
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

Be Seen and Heard at Eye Point
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 Eye Point

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 Assur
  
  X (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…