Manager, Quality Management Systems & Validations
Ocular Therapeutix, Inc.
July 01, 2026
On-site
Bedford, MA
Operations
Position Summary
The Manager, Quality Management Systems & Validations oversees Ocular’s QMS and Quality Assurance Validation activities to ensure compliance with regulatory requirements and Ocular standards. Onsite presence is essential.
Responsibilities
Validations:
- Maintain the validated state of all GxP systems.
- Lead and advise on validation activities, including review/approval of validation protocols and documentation.
- Work cross-functionally on risk assessments and Quality Events tied to validations.
- Lead continuous improvement initiatives for the Validation Program.
- Ensure integrity of data generated by GxP systems.
- Maintain the QA Validation Program in a state of compliance and inspection readiness.
- Serve as SME during regulatory/internal inspections for QA Validation topics.
QMS:
- Lead, plan, and manage Ocular’s QMS; act as technical expert for Quality Events.
- Lead/oversee routine QA activities for Quality Events lifecycle (initiation, investigation, closure).
- Develop and implement QMS policies, schedules, and guidelines.
- Lead the Change Control Review Board forum and guide Change Control record owners.
- Support QMS transformation to optimize systems and improve efficiency.
- Establish communication forums for QMS policies and related topics.
- Participate in cross-functional teams to resolve Quality Events impacting operations.
- Develop, trend, and report Quality Metrics for Deviations, CAPAs, and Change Controls.
- Direct and advise on Facility-related work orders.
- Maintain QMS compliance and inspection readiness.
- Serve as SME during regulatory/internal inspections for Quality Events topics.
Requirements
- Bachelor’s Degree in Life Sciences or related field.
- 10+ years pharmaceutical industry experience with cross-functional experience.
- Experience leading/working in a GxP setting (commercial and/or clinical).
- Experience in e-QMS and compliance.
- Experience supporting Quality Events and validation activities.
- Knowledge of regulatory guidelines (e.g., CFR 210/211, USP, FDA, ICH, MHRA, EMA).
- Experience with external regulatory inspections (e.g., FDA).
- Excellent organizational skills and attention to detail.
- Strong interpersonal, verbal, and written communication.
- Computer literacy; MS Word, Excel, PowerPoint.
The Manager, Quality Management Systems & Validations oversees Ocular’s QMS and Quality Assurance Validation activities to ensure compliance with regulatory requirements and Ocular standards. Onsite presence is essential.
Responsibilities
Validations:
- Maintain the validated state of all GxP systems.
- Lead and advise on validation activities, including review/approval of validation protocols and documentation.
- Work cross-functionally on risk assessments and Quality Events tied to validations.
- Lead continuous improvement initiatives for the Validation Program.
- Ensure integrity of data generated by GxP systems.
- Maintain the QA Validation Program in a state of compliance and inspection readiness.
- Serve as SME during regulatory/internal inspections for QA Validation topics.
QMS:
- Lead, plan, and manage Ocular’s QMS; act as technical expert for Quality Events.
- Lead/oversee routine QA activities for Quality Events lifecycle (initiation, investigation, closure).
- Develop and implement QMS policies, schedules, and guidelines.
- Lead the Change Control Review Board forum and guide Change Control record owners.
- Support QMS transformation to optimize systems and improve efficiency.
- Establish communication forums for QMS policies and related topics.
- Participate in cross-functional teams to resolve Quality Events impacting operations.
- Develop, trend, and report Quality Metrics for Deviations, CAPAs, and Change Controls.
- Direct and advise on Facility-related work orders.
- Maintain QMS compliance and inspection readiness.
- Serve as SME during regulatory/internal inspections for Quality Events topics.
Requirements
- Bachelor’s Degree in Life Sciences or related field.
- 10+ years pharmaceutical industry experience with cross-functional experience.
- Experience leading/working in a GxP setting (commercial and/or clinical).
- Experience in e-QMS and compliance.
- Experience supporting Quality Events and validation activities.
- Knowledge of regulatory guidelines (e.g., CFR 210/211, USP, FDA, ICH, MHRA, EMA).
- Experience with external regulatory inspections (e.g., FDA).
- Excellent organizational skills and attention to detail.
- Strong interpersonal, verbal, and written communication.
- Computer literacy; MS Word, Excel, PowerPoint.