I.      Position Summary:

The Sr. Manager QA Operations is accountable for providing direct QA support to the operations (manufacturing, distribution, etc.) being conducted at Ocular Therapeutix (OTX) in Bedford, MA. This position will closely collaborate in the QA oversight of the production of Drug Products including support of end-to-end operations from technology transfer and clinical production all the way through commercialization.

This is a critical position within the Quality Organization and onsite presence is essential due to the level of cross-functional collaboration that it involves. This position is reporting to the VP, Global Head QA/QC.

II.   Principal Duties and Responsibilities include the following:

• Leading/overseeing routine QA activities associated with site operations, including in-house manufacturing activities as well as those performed at the CDMOs. This also includes activities associated with the distribution of Ocular product through the supply chain workflow.
• Releasing of manufacturing suites and batch/product changeovers for continuation of manufacturing activities.
• Investigating complaints associated with the production of Ocular materials.
• Participating in cross-functional teams to resolve Quality related issues impacting OTX’s operations.
• Reviewing and approving documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations and CAPAs associated with the operations at OTX.
• Developing, trending, and reporting relevant Quality Metrics associated with the area of responsibility.
• Evaluating and approving proposed process changes and improvements in the operational areas, ensuring that appropriate risk assessments are conducted and proposed changes/improvements are consistent with applicable regulatory guidelines.
• Supporting investigations associated with critical or major operational deviations and providing the necessary guidance to authorize operations to continue, as applicable.
• Authoring, reviewing, and approving internal quality documents (SOPs, investigations, etc.).
• Maintaining the QA Operations function in a state of compliance and Inspection readiness.

Other Responsibilities (as applicable):

• Supporting implementation of validation/qualification strategies.
• Performing gap analyses in processes, systems, and practices and recommending and implementing corrective actions and improvements including requalification/revalidation exercises.
• Approving preventive maintenance/calibration, work orders for facilities/utilities and equipment.
• Participating in supplier qualification audits and supporting internal audits and regulatory inspections.

IV.  Qualification Requirements:

• Bachelor’s Degree in Life Sciences or related field.
• 10+ years of experience in the pharmaceutical industry with cross-functional experience.
• Experience working in a GxP setting (commercial and/or clinical).
• Experience in e-QMS and compliance.
• Experience supporting operational activities.
• Knowledge of domestic and international regulatory guidelines such as, CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others.
• Experience with external regulatory inspections (e.g., FDA).
• Excellent organizational skills and attention to
• Strong interpersonal, verbal and written communication
• Computer literacy, proficiency in MS Office, Excel, PowerPoint,