Associate Director, Validation & Process Excellence

Ocular Therapeutix, Inc.; Bedford (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Ocular Therapeutix, Inc. in Bedford, MA is seeking an Associate Director, Validation to provide strategic and technical leadership for validation across clinical development, process qualification, regulatory approval, and commercial launch.

You will lead PPQ, CPV, cold chain shipping validation, and packaging validation, while guiding lifecycle management and regulatory readiness and serving as a SME during inspections.

Qualifications

• Lead validation strategy and execution for PPQ, CPV, cold chain shipping validation, and packaging validation.
• Develop and maintain validation plans, PPQ strategies, protocols, reports, risk assessments, sampling plans, and acceptance criteria.

Responsibilities

• Lead validation strategy and execution for PPQ, CPV, Cold Chain Shipping Validation, and Packaging Validation.
• Develop and maintain product-specific validation plans, PPQ strategies, protocols, reports, risk assessments, sampling plans, and acceptance criteria.
• Lead cross-functional planning and execution of PPQ campaigns to support regulatory approval, commercial launch, and ongoing product lifecycle management.
• Ensure validation strategies appropriately integrate process development knowledge, process characterization, control strategies, equipment readiness, analytical readiness, and manufacturing experience.
• Establish and maintain CPV programs, including process monitoring, trending, evaluation of process capability and variability, and identification of emerging risks or adverse trends.
• Develop and oversee cold chain shipping and distribution validation strategies, including shipping configurations, temperature-controlled transportation, shipping lane qualification, thermal studies, and temperature excursion assessment.
• Provide validation leadership for packaging processes and systems supporting commercial product configuration, transportation, distribution, and product protection.
• Serve as a Validation Subject Matter Expert during regulatory inspections, audits, and CMC discussions.
• Provide technical leadership for validation-related deviations, investigations, change controls, risk assessments, and impact assessments.
• Maintain knowledge of evolving regulatory requirements and drive continuous improvement of validation systems and lifecycle approaches.
• Manage validation resources, consultants, and project priorities and provide

Skills

Validation leadership

Regulatory knowledge

Cross-functional collaboration

Process validation

PPQ

CPV

Regulatory inspections

Risk assessment

Lifecycle management

Project management

Job description

Ocular Therapeutix, Inc. in Bedford, MA is seeking an Associate Director, Validation to provide strategic and technical leadership for validation across clinical development, process qualification, regulatory approval, and commercial launch.

You will lead PPQ, CPV, cold chain shipping validation, and packaging validation, while guiding lifecycle management and regulatory readiness and serving as a SME during inspections.