Associate Director, Quality Control Stability & Lab Operations

Ocular Therapeutix•Bedford, MA

5d•Onsite

About The Position

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. Position Summary The Associate Director of Quality Control (QC) for Stability, Data Review, and Sample Management is a key leadership role responsible for overseeing three critical pillars of the QC organization: the GMP Stability Program, QC Data Review, and Sample Management/Lab Operations. This role ensures the integrity, compliance, and efficient execution of QC activities that support commercial and clinical manufacturing, product release and stability testing, medical device testing, and regulatory submissions. The Associate Director provides strategic direction, manages a high-performing team, drives process improvements, and partners cross-functionally to ensure a robust, inspection-ready quality control function. This position is based on site 5 days per week in Bedford, MA.

Requirements

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.

Nice To Haves

Hands-on experience with LIMS, Empower, or similar electronic data systems.
Prior involvement in regulatory submissions.
Lean/Six Sigma or continuous improvement training.

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.