Auftragsdetails

This position will be responsible for planning and conducting GVP audits as applicable; (vendor (LPPV, CRO, etc.), clinical GVP mock regulatory inspection, PV, internal process, and investigator site) on behalf of clients.  The position of GVP 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 GVP auditing program, policies and strategies and ensuring company compliance to GVP regulations, internal procedures, and policies in cooperation with peers.

*Individual needs to be based in U.S.*

Essential Functions Include:

• The GVP 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) and guidance on Good Pharmacovigilance Practices (GVP).
• The GVP Auditor will be a critical team member who contributes to the implementation of a risk based GVP audit program and provides oversight / management of the GVP consulting program.
• Promote continual improvement regarding customer satisfaction with emphasis on GVP 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 GVP Auditor is responsible for promoting GVP subject expertise through publications and presentations through professional networks.
• The GVP 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 GVP 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 GVP 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 cGVP requirements and standards.
• Utilize expertise of quality systems, data integrity, software compliance and GVP 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 GxP 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 GVP and clinical compliance related activities.

Qualified candidates must have:

• B.Sc./BPharm in scientific discipline as a minimum with experience. MSc/MPharm/MBA plus lead auditor /auditor certification preferred.
• Minimum 10 years of Quality, Compliance, and or auditing experience in related GxP regulated industry.
• Ability to interact in a professional and positive manner with clients and co-workers. 
• Exceptional interpersonal and communication skills.
• Experience working with high performance teams.
• 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.
• An ability to balance and achieve positive results in the areas of safety, quality, productivity, cost and employee relations.
• Ability to organize and manage multiple projects.
• Quality orientation and high attention to detail.
• 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.

• All candidates must be legally eligible to work in United States.
• The role is home based with appropriate travel to undertake assignments on client sites.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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