GCP Quality Specialist

Job Locations US-MA-Bedford
Posted Date 1 month ago(6/17/2021 9:24 AM)
Job ID
2021-1449
# of Openings
1
Category
Quality

Overview

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. 

Responsibilities

· 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

 

Qualifications

· 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

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