Permanent

Associate Director, Global Clinical Quality

SalaryCompetitive
LocationBedminster, New Jersey, United States
SectorPharmaceuticals & Biotechnology

Description

ob Description

 

The Associate Director of GCQA will conduct audits in accordance with approved GCQA Auditing plans to support global and local drug development, registration and marketing activities.  The Associate Director of GCQA will be an integral part of the process established to manage regulatory inspections as part of global marketing submission efforts.

 

Essential Functions

  • Responsible for the coordination and conduct of GCP compliance audits (e.g., vendors, investigator sites and internal processes) in accordance with processes and audit plans
  • Interact with responsible personnel to ensure acceptable and timely Corrective Actions/Preventive Actions are given as part of responses to address audit observations in accordance with GCQA processes
  • Responsible to be an active participant and provide guidance during inspection readiness efforts
  • Serve as a resource for regulatory inspections which may occur, vendors and investigator site locations
  • Development of relationships with cross-functional colleagues to be recognized as a resource for escalation of potential GCP compliance concerns
  • Possesses the ability to properly evaluate GCP compliance concerns based upon the perceived risk taking into consideration the compliance landscape and business objectives
  • Responsible to effectively communicate and assist with implementation of actions to manage GCP compliance concerns raised during inspectional-related activities and issue escalation processes
  • Serve as a subject matter expert for current GCP regulations by staying informed of related quality legislation, guidance documents and industry trends
  • Conduct training sessions to promote GCP awareness and compliance
  • Involvement with the review and revision of Quality procedural documents (e.g., SOPs) to ensure alignment with regulatory requirements and industry landscape
  • Provides guidance and direction to internal and external stakeholders
  • Participates, as needed, in due diligence activities related to potential acquisitions and integration activities for new acquisitions
  • Support implementation of the Quality Compliance Enhancement Program
  • Assists with generating and disseminating GCQA compliance metrics and trends
  • May serve as a mentor for new hires within the GCQA function
  • Provides support for Pharmacovigilance activities, when required

 

 

Minimum Requirements

 

Education / Experience / Skills:

Education

Bachelor’s Degree in Science

Experience

A minimum of 7 years’ experience in the GCP regulated industry.

Demonstrated knowledge, including practical application, of global regulatory standards such as:

  • FDA Code of Federal Regulations, Good Clinical Practice Parts 11, 50, 54, 56, 312 & 314
  • ICH Guidelines Good Clinical Practice (E6 R2)

 

Preferred Skills/Qualifications

  • Experience performing multi-faceted audits from a GCP perspective
  • Experience managing quality compliance plans
  • Experience with regulatory inspections (e.g., EMA, MHRA and FDA)
  • Experience with the audit response and CAPA implementation processes
  • Experience as a clinical study team member
  • Auditing certification (e.g., ASQ)

 

Competencies:

  • Share ideas and builds upon the ideas of others. Shares best practices to improve Projects and tasks
  • Understands the environment they work in and the impact of their decisions
  • Organizes and expresses ideas clearly, and is able to align their work to the company’s vision
  • Able to articulate impact of work on end patient
  • Manages time effectively and demonstrates thoughtful planning as it relates to performance
  • Appropriately voice opinions and concerns to their peers and leadership; shares different points of view on the best course of action for their role and the business
  • Demonstrates openness to explore own strengths and limitations; responds positively to feedback in order to raise self-awareness and improve performance; able to manage and express negative feelings constructively

 

Reporting/Organizational Relationships

Directly Reports to:

Sr Director, GCQ

 

Organizational Relationship/Scope:

  • Development Operations Personnel including Operational and Managerial Levels
  • Clinical Development Personnel including Operational and Managerial Levels
  • Quality Personnel including Operational and Managerial Levels
  • Clinical Research Organizations Personnel including Operational and Managerial Levels
  • Vendor Personnel including Operational and Managerial Levels
  • Regulatory Inspectors
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