What are the responsibilities and job description for the Regulatory Compliance Expert position at ProPharma Group?
**About Us**
ProPharma Group is a leading research consulting organization that has improved the health and wellness of patients for over two decades. We empower biotech, medical device, and pharmaceutical organizations to confidently advance scientific breakthroughs and introduce new therapies.
We partner with our clients through an advisory-build-operate model across the entire product lifecycle. Our expertise spans regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology. This enables us to offer an end-to-end suite of customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
- The GVP Auditor will lead clinical consulting and auditing projects within ProPharma Group, subject matter expertise.
- Execute audits based on experience and comprehensive understanding of federal regulatory requirements and ICH guidance on Good Clinical Practice (GCP) and 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.
Key Responsibilities:
- Keep pace with advances and technological changes in clinical support services within the pharmaceutical/device/biotech industries and promote those that increase the company's effectiveness and profits.
- Provide support to clients and all functional units of ProPharma Group as clinical compliance issues arise, such as deviations and non-conformances.
- Consult on the implementation of proper CAPA to resolve deviations and non-conformances, ensuring compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training.
- Ensure compliance of consulting practices with all applicable internal and external policies, procedures, and industry best practices.
- Generate proposals for GVP auditing and clinical-related projects.
- Assist Operations in staffing client projects to enable efficient execution of the strategic plan and meet revenue and profit goals based on personnel skills development and client needs.
Requirements:
- Audit GVP projects for correct approach, consistency, and quality.
- Ability to interact professionally and positively with clients and co-workers.
- Organize and manage projects efficiently.
- Quality orientation and high attention to detail.
- Strong working knowledge of international cGVP requirements and standards.
- Utilize expertise in quality systems, data integrity, software compliance, and GVP requirements to conduct audits and provide gap analyses and risk assessments for clients.
- 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 translate those instructions into physical execution of tasks.
- Ability to manage and mentor colleagues in company GVP and clinical compliance-related activities.
