Sr Manager, QA Operations

Ocular Therapeutix • Bedford, MA

308d

About The Position

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on innovative therapies for eye diseases using proprietary bioresorbable hydrogel-based formulation technology. The Sr. Manager QA Operations is responsible for providing direct QA support to operations at Ocular Therapeutix in Bedford, MA. This role involves collaboration in QA oversight of Drug Product production, supporting operations from technology transfer to commercialization. The position requires onsite presence for effective cross-functional collaboration and reports to the VP, Global Head QA/QC.

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 detail.
• Strong interpersonal, verbal and written communication skills.
• Computer literacy, proficiency in MS Office, Excel, PowerPoint.

Responsibilities

• Leading/overseeing routine QA activities associated with site operations, including in-house manufacturing and CDMO activities.
• Releasing manufacturing suites and batch/product changeovers for manufacturing activities.
• Investigating complaints associated with the production of Ocular materials.
• Participating in cross-functional teams to resolve Quality related issues impacting operations.
• Reviewing and approving documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations, and CAPAs.
• Developing, trending, and reporting relevant Quality Metrics associated with the area of responsibility.
• Evaluating and approving proposed process changes and improvements, ensuring compliance with regulatory guidelines.
• Supporting investigations associated with critical or major operational deviations and providing guidance for operations to continue.
• Authoring, reviewing, and approving internal quality documents (SOPs, investigations, etc.).
• Maintaining the QA Operations function in a state of compliance and Inspection readiness.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree