GCP/GLP/GCLP Auditor and SOP Technical Writer, QA Compliance Consultant. US based.

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.

This Full-time Exempt position will be for remote Continental USA based and includes possibility of monthly travel for projects (e.g., audits).

The GCP/GLP/GCLP Auditor and SOP Technical Writer, QA Compliance Consultant position is responsible for supporting the management of Clinical CQA related projects and providing Clinical quality consulting, Clinical quality technical writing (e.g., SOP drafting), and contracted services to clients to address quality and regulatory / GCP, GLP, GCLP / issues as necessary. This position will be assigned quality assurance and regulatory / GxP compliance projects within the company. The specific facet of GxP project scopes (e.g., GCP, GLP, GCLP) that the individual can be aligned with to support will be dictated by the practical job experience and training reflected in their CV. Typical CQA projects include QMS Development, QA oversight, Auditing, Cell / Gene therapies, Regulatory agency action response, etc. The Consultant will also be responsible for supporting the design, implementation, monitoring, maintenance, and promotion of ProPharma's CQA program, policies, and strategies in compliance with GCP, GLP, and GCLP regulations, and industry trends.

Essential functions:

• Represent the company in assigned areas of quality assurance and regulatory / GxP

• Provide consultation and support the management of projects within the CQA business practice

• As applicable to project assignment and geographic location, manage and undertake project work on client project scopes, such as GxP auditing, SOP writing/revisions and Quality Management System (QMS) assessments.

• Keep pace with the regulatory and technological changes in the CQA field and develop subject matter expertise to take advantage of those opportunities to increase the company's effectiveness.

• Support departmental overhead tasks such as peer review.

• Be a critical team member who contributes to the implementation and successful execution of risk-based and phase appropriate GxP projects.

• Participates in the sale process as required and assists with the identification of project scope to assist in addressing client needs.

• Support marketing efforts by promotion CQA services through the development of social media content and blogs.

• Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services.

• As applicable, provide CQA specific training to clients and associates within other business units.

• Provide support to clients and all functional units of ProPharma as GxP issues arise. Provide consultation for the implementation of proper CAPA to resolve deviations and non-conformances. Also, responsible for ensuring compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training.

• Directly Engage with employees at all levels to educate on compliance and quality assurance to drive continuous improvement.

• It is anticipated that this position will maintain a percentage of billable project work as determined on a quarterly basis.

• For CQA consultant roles that are primarily focused on auditing, at least 5 audits performed in the past year are preferred.

• Other compliance duties as assigned.

Requirements:

• 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.

• High level of understanding of the criteria for selection for GCP/GLP/GCLP 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.

• 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. 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.