Principal Quality Systems Compliance Specialist

Principal Quality Systems Compliance Specialist

As a Principal Quality Systems Compliance Specialist at EyePoint, you may work from either the Northbridge, MA or Watertown, MA site with a hybrid work schedule.

EyePoint offers robust total rewards in a science‑based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There is 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.

• Own the Quality Systems metrics process.
• Lead and support individuals and teams through root cause analysis investigations.
• Facilitate investigations into quality issues, identify root causes, develop appropriate corrective and preventive actions; track actions and confirm effectiveness.
• Work collaboratively within Quality Assurance functions to gather information and drive timelines.
• Generate and monitor metrics (KPIs) for all Quality Operations regarding Quality Management Review.
• Apply technical expertise of QA/QC and Manufacturing processes to support development and maintenance of cGMP compliant quality systems.
• 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.
• 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.
• Contribute to the development and implementation of continuous quality improvement initiatives.
• 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.
• 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.
• 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 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.
• Preference will be given to someone who has supported quality systems from both a GMP and GCP perspective.

Bachelor of Science or a combination of Bachelor degree and industry experience.

8+ years' experience working in a biopharmaceutical/pharmaceutical environment.

Min
: USD $/Yr.

Max
: USD $/Yr.

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.