Director, Clinical QA

Job Locations US-MA-Bedford
Posted Date 3 weeks ago(1/31/2018 1:41 PM)
Job ID
2018-1049
# of Openings
1
Category
Quality

Overview

The Clinical Quality Assurance function is an essential part of Ocular’s Quality Assurance Department ensuring that clinical trials are in compliance with Good Clinical Practices.  This position will be responsible for ensuring quality systems, procedures, and documentation pertaining to clinical studies are in compliance with applicable US and international standards / regulations. 

Responsibilities

  • Development and implementation of an oversight plan that contains the strategy for clinical quality support for clinical programs as appropriate
  • Responsible for planning, execution, and reporting of audits of clinical investigational sites and central/contract facilities, to ensure that studies of investigational products are conducted in accordance with Good Clinical Practice (GCP) standards, and local and federal regulations
  • Function as a lead auditor when performing audits and authoring audit reports. Follow-up on audit findings until closure
  • Ensure audits of clinical data listings, study reports, and associated clinical and regulatory documents are accurate and adequate for regulatory submissions
  • Provide training with respect to GCPs and assist Clinical Department with GCP training of clinical investigators and study monitors as requested
  • Act as a resource to the Clinical Affairs and Pharmacovigilance Department for GCP and/or quality assurance issues
  • Coordinate and perform GCP audit activities of sites, databases, contract research organizations, and institutional review board and independent ethics committee
  • Conduct a Quality Assurance review of clinical study reports and audit trial master files for applicable regulatory compliance
  • Provide compliance support during regulatory inspections of the company, investigational sites or potential partners as applicable
  • Stay abreast of changes in FDA and European regulations, directive and guidelines and determine its impact on company studies
  • Develop and implement SOPs relating to GCP
  • Other duties as assigned
  • Up to 20% travel

Qualifications

  • Bachelor’s degree in health science or medical field or equivalent
  • 10+ years of experience in the pharmaceutical or biotechnology industry, 5+ years of experience with auditing of clinical trials and associated documentation
  • Strong understanding of applicable regulatory requirements and ICH Guidelines
  • Excellent communication skills
  • Excellent interpersonal and collaborative skills
  • Knowledge of GLP a plus
  • Certified Quality Auditor (CQA) certification preferred

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