New · posted Oct 15
Ocular Therapeutix · Pharmaceuticals
Associate Director, Validation
- Bedford, MA
- On-site
- Full-time
- Director
Open until filled
The role
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.
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.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
What you need
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.
What you'll do
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.
Pay
$187,500 – $200,000 a year
Employer provided$187,500—$200,000 USD
Where you'll work
Bedford, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Bedford, MAEqual opportunity, accessibility and legal noticesOcular Therapeutix's statements, word for word
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $187,500 | — | $200,000 |
This role: Ocular Therapeutix's own published range.
Career trajectory
Where this role sits in Validation & CQV
The general path across 111 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Ocular Therapeutix's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification18
- Collaboration and leadership9
- Quality systems and risk4
- GMP and compliance3
- Documentation and SOPs3
- Investigations and CAPA2
- Regulatory submissions2
- Data and digital systems2
- Lab testing and methods1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
Company hiring pulse
Ocular Therapeutix on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality3 100%
By level
- Associate & Specialist2 67%
- Director1 33%
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Associate Director, Validation at Ocular Therapeutix
Open until filled. $188K–$200K a year, employer provided.