Manager Clinical Quality Assurance

Twitter Facebook
Bridgewater, NJ
$1 - $2
Job Type
Direct Hire
Nov 15, 2018
Job ID
Global Specialty Pharmaceutical company in Bridgewater, New Jersey is looking to hire a Manager of Clinical Quality Assurance

The Manager Clinical Quality Assurance is a key member of the company Research and Development organization. This role is responsible for Clinical QA activity related to the planning, conduct, and reporting of GCP audits in order to ensure that clinical studies are conducted in compliance with applicable regulations, guidelines and company standards. This role also has responsibility for preparation, management, and follow-up of GCP inspections as well as ongoing quality oversight and consultation on clinical studies. This individual actively evaluates and applies audit/inspection outcome learnings and trends to support improvement in clinical trial quality and compliance with company and regulatory requirements. Responsibilities also include leading and/or contributing to identification, development, implementation, management, and enhancement of R&D Quality operational processes, systems, tools and best practices.

Duties and Responsibilities

  • Plan, manage and perform GCP audits of Contract Research Organizations (CROs), systems/processes and clinical Investigator sites for Phase 1 to 4 clinical trials
  • Prepare audit reports and communicate findings to auditees, study team representatives and management
  • Review and assess audit report responses and ensure that corrective and preventative action (CAPA) plans adequately address findings and root cause analysis
  • Evaluate, track and follow up on CAPAs to ensure actions are adequately completed in a timely manner
  • Lead and/or participate in the planning, conduct and follow-up of Regulatory GCP inspections
  • Assess inspection readiness and contribute to development and delivery of Inspection Readiness training for cross-functional team members, as needed
  • Contribute to assessment of reports and results from Regulatory Inspections
  • Assist in preparation of response documents for Site Inspections and Sponsor/CRO Inspections
  • Lead efforts for completion of inspection follow-up activities
  • Participate in regular study team meetings and provide quality oversight and consultation at program/study level
  • Maintain ongoing awareness of program and study issues related to quality, safety and efficacy
  • Provide risk identification/mitigation support for potential and/or identified quality issues
  • Evaluate audit/inspection trends and other information sources to support audit planning and optimize clinical trial quality and compliance
  • Provide GCP compliance consultation on process enhancement/compliance and quality issue management
  • Appropriately escalate quality/compliance issues to management
  • Maintain current industry knowledge of applicable regulations, guidelines, and company standards
  • Evaluate impact of new regulations/guidance, as well as audit results/trends on the business and regulatory risks and provide guidance
  • Contribute to the identification and communication of lessons learned from audits and inspections
  • Travel as needed, up to 30% domestic and internationally

Experience and Qualifications

  • BA/BS degree in relevant discipline or equivalent/relevant work experience required
  • At least 5 years of experience in clinical research and/or a GCP-related environment, with at least 3 years of clinical quality assurance auditing required
  • Extensive working knowledge of international regulations, guidelines and good practices pertaining to clinical trials required
  • Good working knowledge of standard computer office software such as Word, Email system (Outlook), PowerPoint and Excel
  • Strong analytical abilities and attention to detail
  • Ability to work both independently as well as in a team environment
  • Strong organizational and time management skills
  • Ability to prioritize and multi-task successfully in a fast-paced environment
  • Flexibility to manage shifting demands and changing priorities, proactively looking for ways to contribute
  • Excellent verbal and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members
  • Demonstrates critical thinking, sound judgement, and initiative to solve problems
  • Ability to perform all essential functions of the position, with or without reasonable accommodation