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GCP Quality Specialist Job In Ocular Therapeutix, Inc. At
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GCP Quality Specialist

  • Full-Time
  • Bedford, MA
  • Ocular Therapeutix, Inc.
  • Posted 3 years ago – Accepting applications
Job Description
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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