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生產, 美國 | 2021-06-22

GCP 質量運營副總監/總監

Job Title:   Associate Director/Director, GCP Quality Operations Job Category: Exempt/Non-Exempt  
Department/Group:   Quality Assurance Travel Required: Yes, 25%
Location:   Florham Park, NJ Position Type: Full Time
Level/Salary Range:   Mid-Level Hiring Manager VP, Quality Assurance

Primary Functions

  • The Associate Director/Director, GCP Quality will apply deep knowledge of GCP in support of regulatory compliance, clinical risk management, vendor management/oversight, issue management and CAPA, inspection readiness, and inspection/audit management.
  • The position will deliver Quality Assurance oversight from development through commercialization while promoting a quality culture throughout the organization.
  • The position will also support the non-clinical (GLP) team.

 

Major Responsibilities and Duties

  • Fulfills Quality role as defined within the Quality Management System and the Clinical Risk Management System.
  • Support study teams for GCP/GLP compliance, issue management and CAPA, inspection readiness based on strong technical expertise in global regulatory requirements.
  • Plan and lead audits internally, at CROs, vendors, and clinical sites ensuring CAPA implementation and effectiveness.
  • Conduct vendor management and oversight, including implementing clinical quality agreements, in partnership with cross-functional stakeholders.
  • Manage and respond to regulatory inspections.
  • Participate in continuous process improvement projects.
  • Participate in SOP development and periodic review.
  • Provide quality training and communicate best practices and lessons learned.
  • Acts as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations.
  •  

Qualifications and Education Requirements

  • Bachelor degree (required) or higher in scientific, medical or related discipline.
  • 8+ years of experience in the pharmaceutical industry, including 5+ years in GCP Quality.
  • Deep knowledge global regulations and guidelines (e.g. EU Directives, US FDA, PMDA, ICH, and National regulations).
  • Previous experience or advanced understanding of fundamentals of clinical risk management, ICH E6 R2, and upcoming revisions to ICH.
  • Working knowledge of GLP (preferred).
  • Demonstrated critical thinking and problem-solving in the application of global regulations.
  • Inspection management experience (FDA, EMA and other inspectorates).
  • Demonstrated leadership with proactive, collaborative support to cross-functional peers. A team player with strong influencing and negotiation skills.
  • Flexibility to respond to changing business needs.
  • Ability occasionally to work outside of business hours in home time zone to accommodate global team time zones.
  • Experience using data analytics tools and systems preferred.
  • Strong verbal and written communication.
  • Ability to travel up to 25%.