Senior Compliance Consultant / GCP Auditor

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Senior Compliance and Quality Assurance Consultant position is responsible for planning and conducting GCP audits (vendor, internal process and investigator site) and will also include Supporting Quality Management System (QMS) projects such as revising and developing Standard Operating Procedures and Gap analysis projects on behalf of clients. This individual 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 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.

• Candidate must be based in U.S.

Essential Functions

Subject matter lead for clinical consulting and auditing projects within ProPharma Group.

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.

Strong editorial skills for the review and approval of GCP documentation, including protocols, reports, SOPs, etc.

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).

Promote GCP subject expertise through publications and presentations through professional networks.

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.

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.

Perform Customer Service functions in response to client inquiries.

Requirements

Bachelor’s degree in a scientific discipline as a minimum.

Graduate degree (MSc / PhD) in a scientific discipline is preferred.

Minimum 10 years relevant experience in quality assurance and regulatory / GxP compliance.

Experience managing a technology business or business unit or CQA SME lead is preferred.

For Senior Consultant, CQA roles that are primarily focused on auditing, minimum of 3 years’ experience leading audits (e.g., audit prep, running the audit, writing final report, 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.

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.

Based in U.S.

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