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.

• Help in the organization and execution of domestic audits and assessments under the guidance of senior team members.

• Plan and conduct independent audits with support from subject matter experts.

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

• Engage in mock inspections alongside senior consultants.

• Aid in reviewing Standard Operating Procedures (SOPs) and related documentation.

• Take part in audits of investigator sites, Trial Master Files (TMF), vendors, facilities, documents, and systems.

• Prepare audit documentation, reports, observations, and other project deliverables.

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

• Support compliance evaluations, gap analyses, and initiatives for enhancing quality systems.

• Help develop training materials for clients and participate in the delivery of GxP-related training.

• Collaborate with project managers and senior consultants to ensure timelines and client expectations are met.

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

• Contribute to internal process improvement initiatives and perform other assigned tasks.

⛳️ Requirements

• Bachelor's degree in Nursing, Life Sciences, or a related discipline, or a comparable combination of education and experience.

• At least 3–5 years of experience in clinical research, quality assurance, regulatory compliance, or a similar life sciences setting.

• Willingness to travel frequently.

• Preferred 1–3 years of experience in supporting GxP, QA, compliance, auditing, or operational duties.

• Experience in pharmaceutical, biotechnology, medical device, CRO, or similar industries is preferred.

• Basic understanding of Good Clinical Practice (GCP) and other relevant GxP regulations focused on investigator sites is preferred.

• Intermediate proficiency in Spanish is preferred.

• Strong analytical and problem-solving abilities.

• Excellent written and verbal communication skills.

• Capability to manage multiple priorities collaboratively within project teams.

• Proficient in Microsoft Office applications.

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

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

• Ability to understand and follow basic instructions.

• Strong focus and attention to tasks and responsibilities.

• Skills in verbal communication, listening, comprehension, and response.

🏝️ Benefits

• Variable bonus eligibility in addition to base salary.

• Health coverage.

• Paid holidays.

• Equal opportunity workplace dedicated to fostering an inclusive and collaborative environment.

• Opportunities for professional development and continuous learning.