Manager, Quality Management Systems & Validations

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. We strive to build a strong culture where employees can flourish and achieve their career goals, encouraging out-of-the-box thinking, cross-functional collaboration, and creativity.

About the Role

The Manager, Quality Management Systems & Validations is responsible for overseeing and managing Ocular’s QMS and Quality Assurance Validations activities to ensure compliance with regulatory requirements and Ocular standards. This is a critical position within the Quality organization, requiring onsite presence due to the level of cross-functional collaboration involved. This position reports to the Senior Director, Quality Assurance.

Responsibilities

Validations

• Maintaining the validated state of all GxP systems to ensure they operate in a state of compliance with internal procedures, regulatory requirements, and industry best practices.
• Leading, directing, and advising on validation activities, including the review and approval of validation protocols and documentation.
• Working cross-functionally with other departments on projects, including risk assessments and Quality Events associated with validations.
• Leading continuous improvement initiatives for the Validation Program to enhance effectiveness and efficiency.
• Ensuring the integrity of data generated by GxP systems.
• Maintaining Ocular’s QA Validation Program in a state of compliance and inspection readiness.
• Participating as the Subject Matter Expert (SME) during regulatory/internal inspections for QA Validations topics.

Quality Management Systems (QMS)

• Leading, planning, and managing Ocular’s QMS, acting as the technical expert on Quality Events topics.
• Leading/overseeing routine QA activities associated with the lifecycle of Quality Events, including initiation, investigation, and closure.
• Developing and implementing policies, schedules, and guidelines for the appropriate management of Ocular’s QMS.
• Leading the Change Control Review Board forum and providing guidance to owners and collaborators of Change Control records.
• Supporting the transformation of Ocular’s QMS to optimize systems and add efficiency to processes.
• Establishing communication forums to disseminate information on QMS policies and other topics to all Ocular staff.
• Participating in cross-functional teams to resolve Quality Events potentially impacting Ocular’s operations.
• Developing, trending, and reporting relevant Quality Metrics associated with Deviations, CAPAs, and Change Controls.
• Directing and advising on facility-related work orders.
• Maintaining Ocular’s QMS in a state of compliance and inspection readiness.
• Participating as the SME during regulatory/internal inspections for Quality Events topics.

Requirements

• Bachelor’s Degree in Life Sciences or related field.
• 10+ years of experience in the pharmaceutical industry with cross-functional experience.
• Experience leading and working in a GxP setting (commercial and/or clinical).
• Experience in e-QMS and compliance.
• Experience supporting the management of Quality Events and validation activities.
• Knowledge of domestic and international regulatory guidelines such as CFR 210, 211, USP, FDA, ICH, MHRA, EMA, and others associated with QMS and validations.
• 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 Word, Excel, and PowerPoint.

Pay

$143,000 USD - $152,000 USD