Senior Manager, GxP Quality Systems & Validation

Ocular Therapeutix, Inc.; Bedford (MA); On-site; USD 143,000 - 152,000; Full time

Job summary

Ocular Therapeutix, Inc. in Bedford, MA is seeking a senior QA leader to manage the Quality Management System and Validation programs. The role ensures compliance with regulatory requirements and company standards while guiding cross-functional teams.

You will oversee Deviations, CAPAs, Change Controls, and QA Validations, drive continuous improvement, and support inspections as SME. This on-site role reports to the Senior Director, Quality Assurance and requires deep GxP experience.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 10+ years of experience in the pharmaceutical industry.
• Experience leading in a GxP setting (commercial and/or clinical).
• Experience with e-QMS and compliance.
• Experience supporting management of Quality Events and validation activities.
• Knowledge of CFR 210, 211, USP, FDA, ICH, MHRA, EMA guidelines related to QMS and validations.
• Experience with external regulatory inspections (e.g., FDA).
• Strong organizational and communication skills.

Responsibilities

• Maintain the validated state of GxP systems and ensure regulatory compliance.
• Lead validation activities including review/approval of validation docs.
• Collaborate cross-functionally on risk assessments and deviations.
• Drive continuous improvement of the QA Validation Program.

Skills

Organizational skills

Attention to detail

Verbal communication

Written communication

Education

Bachelor's degree in Life Sciences or related field

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Ocular Therapeutix, Inc. in Bedford, MA is seeking a senior QA leader to manage the Quality Management System and Validation programs. The role ensures compliance with regulatory requirements and company standards while guiding cross-functional teams.

You will oversee Deviations, CAPAs, Change Controls, and QA Validations, drive continuous improvement, and support inspections as SME. This on-site role reports to the Senior Director, Quality Assurance and requires deep GxP experience.