Position Summary:

The Associate Director, Validation provides strategic and technical leadership for validation activities supporting the clinical development, process qualification, regulatory approval, and commercialization of Ocular Therapeutix products. This role has primary responsibility for Process Validation, including Process Performance Qualification (PPQ), Continued Process Verification (CPV), Cold Chain Shipping Validation, and Packaging Validation, while providing broader validation leadership and support across the organization as needed.

The Associate Director is responsible for developing and executing validation strategies that demonstrate manufacturing processes, packaging configurations, and product distribution systems are capable, reproducible, and maintained in a state of control throughout the product lifecycle. This individual will play a critical leadership role in PPQ planning and execution, NDA readiness, commercial launch preparation, and ongoing lifecycle management of validated processes.

The Associate Director will serve as a validation subject matter expert during regulatory inspections, health authority interactions, audits, and CMC discussions and will maintain current knowledge of evolving regulatory expectations and industry practices related to process validation, lifecycle management, shipping validation, packaging validation, and continued process verification.

Principal Duties and Responsibilities include the following:

• Lead validation strategy and execution for Process Performance Qualification (PPQ), Continued Process Verification (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 current knowledge of evolving regulatory requirements and industry practices and drive continuous improvement of validation systems and lifecycle approaches.
• Manage validation resources, consultants, and project priorities and provide coaching and development to Validation personnel.
• Support other validation activities, including equipment, facilities, utilities, cleaning, and computerized systems, as needed.

Qualification Requirements:

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Pharmaceutics, or a related scientific discipline required. Advanced degree preferred.
• Typically 12+ years of progressively responsible experience in pharmaceutical, biotechnology, combination product, or medical device manufacturing, with significant validation experience.
• Demonstrated expertise in Process Validation and PPQ, including development of validation strategies, protocols, sampling plans, acceptance criteria, and final reports.
• Strong knowledge of lifecycle Process Validation principles, including Process Design, PPQ, and Continued Process Verification.
• Experience with Cold Chain Shipping Validation, distribution qualification, thermal qualification, and/or Packaging Validation strongly preferred.
• Strong knowledge of cGMP requirements, including 21 CFR Parts 210 and 211, and current FDA, ICH, and applicable global validation expectations.
• Strong understanding of quality systems, including deviations, CAPA, change control, investigations, and risk management.
• Demonstrated ability to evaluate complex technical and manufacturing data and make sound, risk-based decisions.
• Strong cross-functional leadership, project management, communication, and influencing skills.
• Demonstrated ability to manage multiple complex priorities, operate effectively in ambiguous situations, and drive issues to resolution.
• Strong technical writing skills and proficiency with Microsoft Office applications.

Salary Range

$187,500-$200,000 USD