EyePoint Pharmaceuticals, Inc. is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders.
EyePoint Company Values include:
This person will report directly to the VP, Quality and will be responsible for the QA oversight of Contract Manufacturing Organizations (CMO) producing commercial product on behalf of EyePoint. The scope of this role includes external Biological CMO’s and Contract Test Labs (CTLs). This position is responsible for the management & control of North American contract manufacturers, suppliers and QC laboratories (as applicable) in compliance with applicable standards of GMP. This role is responsible for ensuring consistency of approach to management of CMO’s and CTL’s, and for ensuring CMO’s/ CTL’s are in compliance with the regulatory requirements and the expectations of EyePoint.
This role will partner closely with External Supply, Technical support, Disposition, QC, Validation, Regulatory, Site compliance lead, OE, to manage CMO’s and CTL’s, and for ensuring CMO’s/ CTL’s are in compliance with the regulatory requirements and the expectations of EyePoint.Strong collaboration and the ability to effectively work in a matrixed environment is critical to success.
Primary responsibilities include, but are not limited to, the following:
This position is responsible for management of CMO’s / CTL’s within Quality according to EyePoint, GMP standards. This role sets direction and strategy to ensure that EyePoint’s CMO’s /CTL’s are working to the expectation of EyePoint and the required regulations. Sets goals for the function that helps drive strategy execution to enhance and maintain EyePoint’s CMO/ CTL QA oversight in compliance with EyePoint’s US standards.
Primary skills and knowledge required include, but are not limited to the following:
Level of Education Required:
Minimum Bachelor’s degree in engineering, pharmacy, chemistry, biology or a related discipline.
Number of Years of Experience in the Function and in the Industry:
Minimum 5 years’ experience working in a Quality role in the pharmaceutical or medical device industry.