GxP Senior Consultant – Subject Matter Expert

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

📋 Description

• Lead and manage GxP-focused consulting projects, acting as a Subject Matter Expert (SME) across various functions including Quality, Regulatory, Manufacturing, Engineering, and Clinical Operations.

• Develop, assess, and enhance Quality Management Systems (QMS) and regulatory frameworks in accordance with relevant global standards such as FDA, ISO, ICH, EU MDR, MHRA, and Health Canada.

• Offer expert advice on compliance readiness, remediation strategies, and responses to regulatory inspections including FDA 483s, Warning Letters, and audit observations.

• Design, implement, and supervise validation and qualification initiatives, including Process validation, Equipment qualification (IQ/OQ/PQ), Software/CSV (21 CFR Part 11), Cleaning and sterilization validation, and Computerized systems validation.

• Assist in product development initiatives, ensuring compliance with design control, risk management, verification/validation, and DHF/technical documentation standards.

• Conduct gap assessments, root cause analyses, and develop CAPA plans to mitigate quality and compliance risks.

• Act as an advisor to executive teams and technical leaders on regulatory pathways, submission strategies, and lifecycle management.

• Provide project leadership and mentorship to junior team members, ensuring organized execution and high-quality outcomes.

• Prepare and present client-facing reports, technical documentation, strategic recommendations, and training sessions.

• Aid in change management, technology transfer, and scaling initiatives for manufacturing and operations.

• Travel to client sites as necessary.

⛳️ Requirements

• Over 15 years of progressively responsible experience in GxP environments within the pharmaceutical, biotech, medical devices, or life sciences manufacturing sectors.

• Established subject matter expertise in at least one of the following areas: Quality Assurance / Quality Systems, Regulatory Affairs, Validation & Engineering (Process, Equipment, Automation, CSV), Manufacturing Operations / Tech Transfer, Clinical Operations & Compliance, Risk Management (ISO 14971), Design Controls (21 CFR 820, ISO 13485).

• Strong understanding of global GxP regulations and standards (FDA 21 CFR, EU MDR/IVDR, ISO 13485, ICH Q-series, GAMP 5, ISO 9001/62304/17025, etc.).

• Demonstrated capability to lead cross-functional projects and serve as a senior advisor for complex technical issues.

• Previous experience in consulting, advisory, or client-facing technical leadership positions.

• Exceptional communication, documentation, and presentation abilities.

🏝️ Benefits

• Equal Opportunity Employer