VP, Manufacturing & Operational Excellence

EyePoint Pharmaceuticals, Inc.•Watertown, MA

1d•Onsite

About The Position

As our Vice President of Manufacturing & Operational Excellence, you will be both a strategic and a hands-on leader. You’ll set the vision for our manufacturing operations while staying close to the action — actively engaging with teams and solving problems in real time. You’ll ensure we are always FDA inspection-ready, launch-ready, and leading the execution of validation programs that meet global regulatory expectations. Your leadership will accelerate our ability to scale production and integrate new technologies to ultimately improve the lives of patients with serious retinal disease.

Requirements

Proven success in scaling manufacturing operations in highly regulated environments.
Extensive experience leading successful FDA inspections and implementing sustainable inspection readiness programs.
Demonstrated track record of leading commercial product launches and managing full validation lifecycles.
Deep expertise in cGMP, FDA, EMA, and global regulatory frameworks.
Strong financial and operational acumen, with experience managing large budgets and capital investments.
A hands-on leadership style — comfortable moving from the boardroom to the cleanroom to ensure operational success.
Exceptional communication, problem-solving, and change management skills.
A patient-first mindset and a passion for operational excellence.
Bachelor’s degree in engineering, science or a related field required, MS or MBA preferred
20+ years experience in industry with 10-15+ years leadership experience in pharmaceutical manufacturing

Nice To Haves

Experience in sterile manufacturing, biologics, or advanced therapies (cell & gene) is highly advantageous.
PMP, TQM and/or Lean/Six Sigma certification or similar experience preferred

Responsibilities

Lead and inspire a multi-site manufacturing network, embedding a culture of safety, quality, and continuous improvement.
Develop and execute a forward-looking manufacturing strategy aligned with corporate growth, regulatory compliance, and market needs.
Oversee production planning and execution to ensure we meet global commercial and clinical demand requirements.
Lead commercial product launch — from late-stage tech transfer through process validation, regulatory submission support, and market release.
Ensure 24/7 FDA inspection readiness — lead preparation, host inspections, and drive timely, effective responses to observations.
Drive validation strategy and execution, including process, cleaning, equipment, and computer system validation to ensure cGMP compliance.
Maintain full compliance with FDA, EMA, and other global regulatory bodies, upholding world-class cGMP standards.
Partner with R&D, Quality, Supply Chain, and Commercial teams to accelerate product launch and optimize lifecycle management.
Champion operational excellence through Lean, Six Sigma, and Industry 4.0 digital manufacturing initiatives.
Support preparation of regulatory submissions.
Support large-scale capital projects, including facility expansions, automation upgrades, and continuous process improvement initiatives.
Lead and direct manufacturing on an operational level — actively engaging with front-line leaders & manufacturing associates, and assisting with troubleshooting issues, modeling a “roll up your sleeves” leadership style.
Build, mentor, and retain top-tier manufacturing leadership talent.
This role will require an on site presence in both the Watertown and Northbridge locations.