Ocular Therapeutix, Inc GCP Quality Specialist in Bedford, Massachusetts
This position will be responsible for all Quality GCP and GLP activities. Responsibilities will be to ensure quality and compliance of Ocular Therapeutix-sponsored nonclinical and clinical studies with respect to Standard Operating Procedures, applicable regulatory requirements (FDA/EU/ICH/country-specific and current industry standards and practices). Additional activities will be to create systems and documentation that support phase appropriate quality oversight.
· Develop and implement detailed audit plans and yearly GCP/GLP master audit schedules
· Work with contract auditors on scheduling, preparation, conduct of audits; review audit reports, review/follow-up on responses, and file all audit-related documentation
· Schedule, prepare for and conduct audits (investigator sites, vendors (GLP/GCP), internal process, Trial Master File and document audits (e.g. Clinical Study Reports, Investigator Brochures, GLP reports and other submission reports) as needed, write audit reports and review/follow-up on responses
· Assist in the development of phase appropriate, GLP/GCP, development, and quality SOPs
· Attend study team meetings and provide GCP and GLP guidance/advice
· Ensure the timely and effective follow-up of all identified or assigned quality issues through a Corrective Action/Preventive Action (CAPA) system
· Support gap analyses and updates to the Quality Management System from a risk-based perspective
· Assist in the development/implementation of an Inspection Readiness program and assist during regulatory authority inspections
· Assist with metric and trending of Key Quality Indicators
· Bachelor’s Degree in a scientific discipline or relevant education and applicable job experience required
· Minimum of 5 years in the Pharmaceutical industry in GCP and /or GLP QA (preferred)
· Solid understanding of GLP, GCP and ICH clinical requirements
· Experienced GCP auditor in the role of lead.
· Experience with both domestic and international clinical studies
· Excellent writing, organizational and collaboration skills
· Able to travel domestically and internationally approximately 25-30% of the time
· Regulatory inspection experience is a plus
External Company Name: Ocular Therapeutix, Inc.
External Company URL: http://www.ocutx.com/
Street: 15 Crosby Drive