GCP Auditor

Title:  GCP Auditor

 

We have been asked to staff a GCP Auditor opening, permanent position, for one of our well established and world reknowned pharmaceutical clients in NJ.

This is an office-based permanent position requiring up to 60% US travel, with occasional travel to Canada.

 

Position Summary:

Participate in the administration of GCPQA systems and procedures to monitor the quality, efficiency, uniformity and compliance of clinical-related systems, procedures and trials, both internally and externally.

 

Role Responsibilities:

• To prepare, conduct, report and follow-up on audits of local and/or international clinical studies and related clinical systems and procedures, to ensure that they are in compliance with applicable regulations, Good Clinical Practices (GCP) guidelines, and Company quality standards. The Scope of these audits will include, but is not limited to, clinical investigator sites, contract research organizations (CROs), and Company clinical systems, processes and documentation relevant to the area of clinical trials.

• To assist the Associate Vice President, GCP and Director, GCP of US Quality and Compliance in the management of information flow between the GCP QA group and its customers in the Medical Affairs Department, and follow-up on the audit program, relative to specific projects.

• To respond effectively to the demands and changes in the regulatory environment, advising operational management and staff on the impact of this environment on the company and be proactive to determine the adequacy of on-going programs.

• To assist the Associate Vice President, GCP and Director, GCP of US Quality and Compliance in the preparation and presentation of GCP oriented training programs to the organization to improve the understanding and knowledge of the members of the clinical team.

• Demonstrates required competencies on a consistent basis • Demonstrates company values on a consistent basis • Performs other duties as requested.

 

Requirements—

Education:

• BA/BS required from an accredited school in a medical or scientific discipline. 

 

Experience:

• A minimum of two years quality assurance related experience in the pharmaceutical industry.

 

Professional Skills:

• Current, in-depth knowledge of the regulatory requirements and international guideline governing the conduct of domestic and international clinical research studies. Ability to communicate ideas in a positive manner and participate in a team environment. Strong interpersonal, communication skills.

 

Job Specific Competencies:

•  Understands dynamics of the industry as well as stays current with development and factors that can affect regional and corporate goals, as well as uses this knowledge for competitive advantage.

•  Makes Customers and their respective needs a primary focus of individual actions, as well as develops and maintains productive customer relationships.

•  Develops and uses collaborative relationships to facilitate the accomplishment of work goals. Focuses on future growth as a team, and also on sharing, encouraging and actively engaging colleagues.

•  Uses appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.

•  Regularly takes advantage of opportunities for professional growth through learning, and uses newly acquired knowledge and skills on the job and through demonstrated application.

•  Adds value to the organization by assuming responsibility and accountability for successfully completing assignments or tasks; proactively takes action to complete goals and objectives.

 

PLEASE RESPOND TO Pat Dowens -- pdowens@thinkcentric.com