Ocular Therapeutix, Inc. · 4 hours ago
Associate Director, Quality Control for Stability & Lab Operations
Bedford, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$160K/yr - $175K/yr
10+ years expOcular Therapeutix, Inc. is a biopharmaceutical company focused on innovative therapies for eye diseases. The Associate Director of Quality Control for Stability, Data Review, and Sample Management is responsible for overseeing critical QC functions, ensuring compliance, and driving process improvements within the organization.
BiotechnologyHealth CareMedical Device
Responsibilities
Lead and develop the Stability, Data Review, and Sample Management teams, ensuring strong organizational capability, accountability, and engagement
Establish short- and long-term strategies that support company growth, new product introductions, and evolving regulatory expectations
Serve as a QC subject matter expert (SME) during audits and inspections (FDA, ISO, EMA, Notified Bodies), providing expertise on stability programs, data integrity, and sample handling
Promote a culture of quality, compliance, and continuous improvement
Own the GxP stability program, including design, execution, monitoring, and reporting for drug substance, drug product, raw materials, and medical device components
Ensure stability studies comply with ICH, ISO 13485, and FDA/EMA requirements
Oversee the stability protocol creation, change control, pull schedules, sample storage, and data trending
Review and approve stability reports for regulatory filings, annual reports, and product lifecycle management
Optimize chamber utilization, environmental monitoring, and change control of stability infrastructure
Lead the QC data review function, ensuring timely, accurate, and cGMP-compliant review of analytical data
Implement and maintain data integrity systems aligned with ALCOA+ principles
Oversee review of chromatography data, microbiology data, device test data, and characterization results
Drive improvements in electronic data systems (e.g., LIMS, Empower, eQMS) to enhance automation, compliance, and efficiency
Support investigations, OOS/OOT events, deviations, CAPAs, and root-cause analysis activities from a data/integrity standpoint
Oversee sample management across Quality Control & Analytical Development with manufacturing and external partners
Ensure compliant receipt, labeling, chain-of-custody, distribution, storage, and archival of all GxP samples
Manage retention samples for pharma and medical device requirements
Ensure sample flow readiness for release, stability pulls, qualification/validation, and device testing
Lead optimization initiatives for LIMS workflows, inventory control, and sample logistics
Ensure full compliance with cGMP, GLP, ICH, FDA, and ISO 13485 requirements across all functional areas
Author, review, and approve SOPs, protocols, investigations, and technical assessments
Support risk assessments, audit responses, and regulatory submissions
Ensure all operations are audit-ready and consistently inspection-compliant
Collaborate closely with QA, Manufacturing, Supply Chain, Regulatory Affairs, and Product Development
Provide technical insight for regulatory queries, partner communications, and quality agreements
Qualification
Required
Bachelor's or Master's degree in Chemistry, Biochemistry, Biology, Engineering, or related scientific discipline
10+ years of experience in Quality Control within biotech, pharmaceutical, or medical device industries
5+ years of leadership/management experience with proven mentorship and team-building capability
Strong working knowledge of cGMP, ICH Q1A, ISO 13485, and global data integrity expectations
Experience managing stability programs, data review teams, or sample management functions
Demonstrated ability to lead through audits and regulatory inspections
Preferred
Hands-on experience with LIMS, Empower, or similar electronic data systems
Prior involvement in regulatory submissions
Lean/Six Sigma or continuous improvement training
Company
Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to redefining the retina experience across drug development, treatment, and outcomes.
51-200 employees
H1B Sponsorship
Ocular Therapeutix, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (1)
2023 (3)
2022 (4)
2021 (10)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.19BKey Investors
Ascension VenturesPolaris Partners
2025-09-30Post Ipo Equity· $475M
2024-02-22Post Ipo Equity· $325M
2023-12-13Post Ipo Equity· $115.11M
Leadership Team
Pravin Dugel
Executive Chair, President, and CEO
Michael Goldstein
Chief Strategy Advisor
Recent News
2026-01-24
2026-01-23
2026-01-23
Company data provided by crunchbase