Sr. Manager/Associate 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 reporting to the Director, Clinical Quality Assurance.

Responsibilities

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

 

Individual Responsibilities

The Associate Director/Senior Manager of Clinical Quality will develop, manage, and improve existing quality systems to ensure appropriate controls for EyePoint in-house GCP capabilities. 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 be responsible for CQA aspects of vendor (i.e. CROs) oversight including audits, establishment of Quality Agreements, and major deviation review. This position will support the BioResearch Monitoring Program (BIMO) inspection readiness initiative, as well as QA support of post approval pharmacovigilance systems.  Works directly with EyePoint Clinical Operations, Development, Biometrics and Pharmacovigilance departments to provide continual oversight to enforce requirements and meet guidelines. This position reports to the Director, Clinical Quality Assurance.

 

• Represent and promote clinical quality and compliance vision and mindset for the entire company.
• 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.
• Provide Quality Assurance oversight, compliance support and be the QA represent for EyePoint Clinical Program/Study Teams.
• Conduct audits of CROs and vendors, clinical sites, and clinical systems/software and databases.
• Follow-up with vendors to ensure any audit observations are closed appropriately.
• Conduct internal audits and follow-up for closing investigations and audit observations.
• Lead clinical affairs in sponsor deviation and investigation process
• Ensure that sponsor deviations are analyzed for corrective and preventive actions (CAPAs).
• Oversee all aspects of Quality related to execution of assigned clinical studies.
• Prepare for FDA/Health Authority inspections of EyePoint or clinical sites.
• Provide leadership, guidance, and direction to staff consistent with GCP.
• Participate in initiatives related to critical quality processes such as essential document management, eTMF, data management, trial management, investigational product management, etc.
• Ensure standard procedures are updated to reflect current regulations, technological changes, trends, and best practices.
• Ensures adherence to GCP requirements and SOPs including training plans and executed training.
• Foster an environment that supports compliance and drives continuous improvement activities.
• Takes lead role in organizing and completing investigations, coordinates with other departments involved, and drives closure in a timely manner.
• Provide routine communication to the Leadership Team about the overall status of the Quality Management System.
• Performs other duties as assigned.

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:

• Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.
• Experience interacting with regulatory health authorities at pre- and post-approval inspection.
• Established expertise and training in GCP systems.
• Experience with FDA, ICH and EMEA guidelines and regulations