Job Description

The Executive Director, Quality Assurance, is responsible for overseeing and managing the day-to-day activities of the Quality Assurance department as they relate to support of CMC, Technical Operations, Regulatory Affairs, Medical Affairs, Clinical Operations and Commercial Operations. The Executive Director, Quality Assurance serves as representative on all applicable committees and assures proper compliance with and continual improvement of the Verrica Quality Management System. The Executive Director, Quality Assurance, functions as the Management Representative for site Quality Assurance Operations during regulatory inspections and manages the QA departmental budget.

RESPONSIBILITIES

• QA review of documents and records and disposition of associated product(s) for CMC/Development, Clinical and Commercial Operations
• Quality Management oversight of third-party manufacturing, packing and testing laboratory sites
• Oversee customer product complaint investigation processes from CMOs
• Assure proper compliance with and continual improvement of QMS
• Travel to third party sites as required
• Maintenance of the Verrica Quality System
• Management of Quality Associate(s)

EDUCATION AND EXPERIENCE REQUIREMENTS

• BS in a scientific discipline required, MS preferred
• At least 15 years prior experience with pharmaceutical and/or medical device environments
• Knowledge of 21 CFR210 and 211 and 21 Pharmaceutical, CFR820 Medical Devices and Part 4 Combination Products
• Experienced in both pre-commercial Quality support to Clinical. R&D/CMC as well as Quality support for Commercial Operations
• Prior experience working with combination devices (pharmaceutical and medical device)
• Prior experience in working with CMO, CRO, CTLs and business partners required
• Prior experience in hosting FDA inspections and coordination of back-room operations during inspections
• Experience in conducting third-party compliance audits
• Experience in working with an electronic QMS

PHYSICAL POSITION REQUIREMENTS

Must be able to sit for extended periods of time at a desk. Normal requirements for office operations with respect to lifting, standing and walking. The position will require travel, sometimes frequent, during routine responsibilities.

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