Principal Quality Systems Compliance Specialist

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 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.

Responsibilities

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

Individual Responsibilities

• 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
  
  

Qualifications

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 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
  
  

Other 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 perspective
  
  

Level 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.

Min

USD $124,630.00/Yr.

Max

USD $157,590.00/Yr.