GCP Compliance & QA Consultant.

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.
• 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.
• Be a critical team member who contributes to the implementation and successful execution of risk-based and phase appropriate GxP projects.
• Participate in the sales process as required and identify scope and effort required to successfully address client needs.
• Support marketing efforts by promoting 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 such as deviations and non-conformances arise.
• Provide consultation for the implementation of proper CAPA to resolve deviations and non-conformances.
• Ensure compliance of company operations to quality principles and participate 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.

Necessary Skills And Abilities

• Knowledge of applicable US FDA, ICH, EMA, MHRA regulations and guidance documents.
• Expertise in GxP systems and capable of providing consultation based on previous experience and system knowledge.
• Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and execution of a project.
• Willingness and ability to travel as required.
• Ability to interact in a professional and positive manner with clients and co-workers through strong interpersonal and communication skills.
• Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information / instructions accurately in English and one other European language preferred (for EU employees).
• Quality orientation and high attention to detail.
• Strong analytical skills.

Necessary Education

• Bachelor’s degree, or similar college degree, in a scientific discipline as a minimum.
• A graduate degree (MSc / PhD) in a scientific discipline is preferred.
• As applicable, eligible to be registered as a Qualified Person (QP), Responsible Person (RP) and Responsible Person import (RPi).

Experience Requirements

• Minimum 5 years relevant experience in quality assurance and regulatory / GxP compliance.
• As applicable, previous registration as a Qualified Person.
• Strong working knowledge of GxP principles including the Code of Federal Regulations (CFRs) and EU GMP / GDP regulations.
• For Consultant, CQA roles that are primarily focused on auditing, minimum of 1 year experience leading audits (e.g. audit prep, running the audit, writing final report, etc.) and recent auditing experience is required (at least 5 audits performed in the past year as reflected in the candidate’s audit log).