Director Clinical Quality Assurance

US$235000 - US$240000 per annum
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United States
New Jersey, USA
Posting date: 17 Jun 2024
60935

Director Clinical Quality Assurance - Permanent - New Jersey

Proclinical is seeking a dedicated and talented individual for the role of Clinical Quality Assurance, Director.

Primary Responsibilities:

This role is integral to the company's mission of transforming cancer therapy and improving patient outcomes. The successful candidate will be part of a team that manages quality throughout all stages of clinical trials. This role involves designing and implementing efficient clinical trial protocols, managing compliance systems, and ensuring readiness for Good Clinical Practices (GCP) Sponsor Inspections.

Skills & Requirements:

  • A degree in a scientific or health-related discipline.
  • Experience in the biopharmaceutical industry or at a Contract Research Organization.
  • Experience in clinical quality risk management, quality assurance, or GCP auditing.
  • Knowledge of ICH GCP and relevant global regulations and guidelines.
  • Experience interacting with inspectors and cross-functional, global teams.
  • Experience working in an outsourced model for clinical trials is preferred.
  • Strong project management skills and attention to detail.
  • Excellent verbal, written, and interpersonal communication skills.
  • Ability to travel globally when required.

The Director Clinical Quality Assurance's responsibilities will be:

  • Lead the development and implementation of a risk management methodology and Quality Risk Management plan for clinical studies.
  • Conduct internal risk review meetings to manage risks to quality.
  • Collaborate with Quality Assurance to ensure organizational alignment.
  • Establish quality thresholds and indicators across all studies.
  • Communicate risks to Management and identify areas of risk to Quality across studies.
  • Participate on assigned study teams, providing quality review and input during the development of key clinical documents and training materials.
  • Support the development of corrective and/or preventive actions post-audit.
  • Lead Regulatory Inspection preparation activities for study teams and provide support during inspections and internal audits.
  • Manage the completion and execution of CAPA deliverables under the CMO organization.
  • Lead the CMO Center of Excellence for the development and review of processes and procedures governing the conduct of Clinical Trials.
  • Support the development and delivery of training specific to clinical trial conduct.

Compensation:

  • $235,000 to $240,000

If you are having difficulty in applying or if you have any questions, please contact Joshua Godden on J.Godden@Proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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