Consultant, GxP Services

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist consultants in providing GxP consulting services for clients in the pharmaceutical, biotechnology, medical device, and life sciences sectors.

• Aid in the planning and execution of domestic audits and assessments under the guidance of senior team members.

• Organize and conduct independent audits with support from subject matter experts (SMEs).

• Contribute to inspection readiness activities as a co-auditor.

• Engage in mock inspections alongside senior consultants.

• Support the review and documentation of standard operating procedures (SOPs).

• Facilitate client communications with the project team.

• Partake in continuous improvement initiatives and consulting projects.

• Involve in audits related to investigator sites, TMF, vendors, facilities, documents, and systems.

• Prepare documentation for audits, including reports, observations, and essential project deliverables.

• Assist in quality control reviews of project documentation and data.

• Support compliance assessments, SOP reviews, gap analyses, and initiatives aimed at improving quality systems.

• Aid in the creation of client training materials and participate in the delivery of GxP-related training.

• Collaborate with project managers and senior consultants to adhere to timelines and meet client expectations.

• Stay updated on relevant GxP regulations and industry best practices.

• Contribute to internal process improvement initiatives and undertake other assigned responsibilities.

⛳️ Requirements

• Bachelor's degree in Nursing, Life Sciences, or a related field, or an equivalent combination of education and experience.

• A minimum of 3-5 years of experience in clinical research, quality assurance, regulatory compliance, or a similar life sciences environment.

• Willingness to travel extensively, with travel required up to 50%-70% of the time.

• 1-3 years of experience in supporting GxP, QA, compliance, auditing, or operational functions.

• Experience within pharmaceutical, biotechnology, medical device, CRO, or related sectors.

• Foundational understanding of GCP and other relevant GxP regulations, particularly those focused on investigator sites.

• Intermediate fluency in Spanish.

• Proven analytical and problem-solving abilities.

• Excellent written and verbal communication skills.

• Capability to manage multiple priorities collaboratively within project teams.

• Proficiency in Microsoft Office applications.

• Ability to sit or stand for extended periods at a stationary workstation.

• Capability to regularly lift, carry, and lower objects weighing up to 10 lbs.

• Ability to learn and understand basic instructions.

• Strong focus and attention to tasks and responsibilities.

🏝️ Benefits

• Variable bonus eligibility in addition to the base salary.

• Health coverage.

• Paid holidays.

• Additional benefits.

• Opportunities for professional development and continuous learning.