Manager - GCP Compliance

Job Locations US-MA-Bedford
Posted Date 3 months ago(5/11/2020 1:46 PM)
Job ID
2020-1322
# of Openings
1
Category
Quality

Overview

 

As a member of the Quality Assurance team, establish, maintain and continually develop the Ocular Therapeutix quality management system to ensure product development and clinical activities are conducted in compliance with global GCP guidelines and the data generated from those activities is reliable. The role is responsible for ensuring the company is GCP inspection ready at all times.

Responsibilities

  • Establish and maintain a framework which at all times meets with global GCP guidelines.
  • Collaborate with other departments involved in GCP activities to ensure adherence to current guidance and best practices.
  • Partner within Quality Assurance to ensure the GMP aspects of development and clinical activities are addressed and in compliance with current guidelines.
  • Ensure oversight and adherence to GCP regulations so the company is inspection ready at all times, enabling the company to execute its current and future development programs.
  • Support the Supply Chain Quality Assurance team in the internal and external audit program for GCP purposes.
  • Develop and maintain our company pharmacovigilance system and collaborate with Clinical and Medical teams to assess and address post-market surveillance reports.
  • Conduct clinical data integrity reviews to ensure data is reliable in support of regulatory dossiers.
  • Collaborate with QA Quality Systems to develop, conduct and continually improve the GCP trainings provided.
  • Contribute to the development, monitoring and reporting of metrics.
  • Act as audit host in GCP regulatory inspections.

 

Qualifications

  • Bachelor’s degree in a related field with at least 5 years working in a GCP environment.
  • Excellent knowledge of US cGCP guidance and a good understanding of global GCP guidance.
  • An understanding of GMP for medicinal products.
  • Previous experience hosting GCP regulatory inspections.
  • Ability to provide clear, concise responses to compliance inquiries.
  • Demonstrated experience conducting compliance auditing is preferred.
  • Pharmacovigilance experience preferred.
  • Strong interpersonal, communication, presentation and negotiation, skills
  • 20% travel anticipated.

 

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