GCP Quality Specialist

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