Director, Clinical Quality Assurance

Overview

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 is remote and is reporting to the Sr. Director, Global Quality Assurance.

Responsibilities

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

 

Individual Responsibilities

The Director of Clinical Quality will manage a team of clinical quality assurance professionals, where they will develop, manage, and improve existing quality systems to ensure compliance with GCP for EyePoint in-house and external activities. This includes the expansion of existing Clinical Quality Management System (QMS), development of documents, training of personnel, and quality oversight of clinical development. This position will lead the BioResearch Monitoring Program (BIMO) inspection readiness initiative, as well as provide QA support of post approval pharmacovigilance systems.  Works directly with EyePoint Clinical Operations, Development, Biometrics and Pharmacovigilance leadership to provide continual oversight and foster continued GCP compliance. This position reports to the Senior Director, Global Quality Assurance.

 

• Collaborate with Senior Management to lead, implement, and continuously improve the QMS by establishing quality goals and initiatives, and ensuring compliance to applicable global regulations and standards, such as FDA and ICH.
• Drive the clinical quality and compliance vision and mindset of the entire company in close collaboration with the senior leadership team.
• Help to define clear CQA objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions, and drive risk analysis and mitigation strategies.
• May conduct audits of CROs and vendors, clinical sites, and clinical systems/software and databases.
• Oversee all aspects of Quality related to execution of clinical studies.
• Monitor and track quality metrics to identify trends and areas of improvement
• Drive initiatives related to quality process improvement
• Represent GCP Quality Assurance at internal meetings and provide input from a CQA perspective
• Lead and/or assist with FDA/Health Authority inspections of EyePoint or clinical sites.
• Provide leadership, guidance, and direction to staff consistent with GCP.
• Lead company in conducting risk assessments and implement proactive measures to prevent and address quality issues, deviations, and non-conformances within the GCP context.
• Oversee processes to ensure standard procedures are updated to reflect current regulations, technological changes, trends, and best practices.
• Participate in the selection and evaluation of vendors, ensuring that they meet quality standards and regulatory requirements
• Provide routine communication to the Senior Leadership Team about the overall status of the Quality Management System.
• Keeps current with GCP quality and regulatory surveillance, as well as trends, and shares information with applicable personnel.

Other Requirements:

• Travel will be required to facilitate robust partnerships and execution.
• Depending on growth of organization and the primary work location, travel is estimated to be up to 20%

Qualifications

Primary skills and knowledge required include, but are not limited to the following:

• Extensive knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
• Experience interacting and/or leading regulatory health authorities at pre- and post-approval inspection.
• Demonstrated ability to build rapport with team members and partners
• Excellent organization skills, attention to detail and ability to handle multiple competing and changing