Job Description

The GCP Auditor will be responsible for planning and conducting GCP audits (vendor (CRO), clinical mock regulatory inspection, PV, internal process and investigator site) on behalf of clients.  The position of GCP Auditor will also act as a Subject Matter Expert (SME) for clinical-related projects and will be responsible for developing and managing the clinical auditing program.  This position is responsible for independently managing clinical-related projects and providing consulting and contract services to clients as needed.  This position is also responsible for assisting with designing, implementing, monitoring and maintaining ProPharma Group’s clinical auditing program, policies and strategies and ensuring company compliance to GCP regulations, internal procedures and policies in cooperation with peers.

Essential Functions Include:

• The GCP Auditor will be subject matter lead for clinical consulting and auditing projects within ProPharma Group. 
• Execute audits based on experience and a comprehensive understanding of all federal regulatory requirements and ICH (International Council for Harmonization) guidance on Good Clinical Practice (GCP).
• The GCP Auditor will be a critical team member who contributes to the implementation of a risk-based GCP audit program and provides oversight / management of the GCP consulting program.
• Promote continual improvement regarding customer satisfaction with emphasis on GCP consulting services.
• Keep pace with advances and technological changes in clinical support Services within the pharmaceutical / device / biotech industries and promote those that will increase the company’s effectiveness and profits.
• Provide support to clients and all functional units of ProPharma Group as clinical compliance issues such as deviations and non-conformances arise.  Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances.  Also, is responsible for helping to ensure compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training.
• The GCP Auditor is responsible for promoting GCP subject expertise through publications and presentations through professional networks.
• The GCP Auditor will provide ongoing support and expertise to all personnel, assisting them in establishing goals, objectives, policies, and procedures for all applicable subsets of this business unit within the company.
• Help to ensure the consulting practices are in compliance with all applicable internal and external policies procedures, and industry best practices.
• Generation of proposals for GCP auditing and clinical-related projects.
• Assist Operations in staffing client projects to enable the company to execute the strategic plan efficiently and effectively, and to meet revenue and profit goals based on personnel skills development and client needs.  Includes candidate interviewing skills.
• Audit GCP projects for correct approach, consistency, and quality.
• Ability to interact in a professional and positive manner with clients and co-workers. 
• Ability to organize and manage projects.
• Quality orientation and high attention to detail.
• The role will guarantee the continued success of the company by ensuring that all employees, contractors and the company as a whole meet or exceed established quality and compliance guidelines.
• Strong working knowledge of international cGCP requirements and standards.
• Utilize expertise of quality systems, data integrity, software compliance and GCP requirements to conduct audits and provide Gap analyses and risk assessments for clients.
• Perform Customer Service functions in response to client inquiries.
• Strong editorial skills for the review and approval of GCP/GMP documentation, including protocols, reports, SOPs, etc.
• Effective written and oral communication skills; ability to write, type, express or exchange ideas by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
• Ability to manage and mentor colleagues in company GCP and clinical compliance related activities.

Qualifications

Qualified candidates must have:

• B.S./B.A in scientific discipline as a minimum.  A graduate degree in a scientific discipline is preferred.
• Minimum 10 years of clinical compliance and GCP auditing experience in related industry.
• Minimum 5 years managing a technology business or business unit or applicable related experience.
• Ability to interact in a professional and positive manner with clients and co-workers. 
• Exceptional communicator with strong persuasion skills and presentations.
• Excellent interpersonal and communication skills.
• High level of understanding of the criteria for selection for GCP and clinical compliance consulting services in the pharmaceutical, medical device and biotech industries. 
• Knowledge of the sales process in these industries. 
• Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and directing of a project. 
• Proven record with team leadership, problem solving, project tracking and budgeting, and facilitation of efficient communication between the client and the team. 
• Experience creating and working with high performance teams.
• Ability to organize and manage multiple projects.
• Quality orientation and high attention to detail.
• Demonstrated ability to lead people and get results through others.
• Ability to think ahead and prepare action plans to achieve results.
• Supervisory experience, including employee hiring and retention, performance review and discipline.
• An ability to balance and achieve positive results in the areas of safety, quality, productivity, cost and employee relations.
• Excellent analytical skills and the ability to access and resolve difficult business situations.
• Ability to read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.
• Must be willing to travel nationally throughout the US.

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.