Associate Director, Clinical Quality Assurance

October 20

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Ocular Therapeutix, Inc.

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ocular drug delivery • surgical sealants • sustained delivery • ophthalmic therapies • ophthalmology

51 - 200

Description

• Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on innovative therapies for eye conditions. • The Clinical Quality team ensures the clinical quality management system fosters quality innovation. • You will provide global GCP guidance for cross-functional development teams and enhance a culture of quality. • Participate and lead GCP inspections by regulatory authorities and manage readiness activities globally. • Support and/or lead issue management and corrective/preventive action activities. • Develop and implement risk-based audit plans. • Support efforts to identify and implement new technologies to optimize quality.

Requirements

• The ideal candidate will have experience conducting and managing GCP audits and directly supporting Clinical Study Teams. • 10 years of GCP Quality Experience • Strong understanding of GCP (e.g., ICH GCP E6 R2; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Directive). • Understanding of global clinical and safety regulations. • Experience managing and executing GCP audits. • Ophthalmology experience is a plus. • Ability to effectively escalate quality concerns to Clinical Quality leadership. • Ability to manage multiple simultaneous projects. • Excellent communication and writing skills. • Commitment to diversity, equity, and inclusion. • Able to travel ~40% of the time.