GxP Sr. Consultant / Subject Matter Expert - Life Sciences

This is a remote position. We are seeking deeply experienced industry professionals with strong technical judgment, hands-on expertise, and a proven record of delivering high-impact consulting projects. Ideal consultants are seasoned practitioners with 15+ years of experience and domain depth in GxP operations, regulatory compliance, quality systems, validation, engineering, and/or clinical operations. Key Responsibilities • Lead and deliver GxP-focused consulting engagements, serving as an SME across multiple functions such as Quality, Regulatory, Manufacturing, Engineering, and Clinical Operations. • Develop, review, and optimize Quality Management Systems (QMS) and regulatory frameworks aligned with applicable global standards (FDA, ISO, ICH, EU MDR, MHRA, Health Canada, etc.). • Provide expert guidance on compliance readiness, remediation, and responses to regulatory inspections (FDA 483s, Warning Letters, audit observations). • Design, execute, and oversee validation and qualification programs: • Process validation • Equipment qualification (IQ/OQ/PQ) • Software/CSV (21 CFR Part 11) • Cleaning and sterilization validation • Computerized systems validation • Support product development programs, ensuring adherence to design control, risk management, verification/validation, and DHF/technical documentation requirements. • Perform gap assessments, root cause investigations, and CAPA development to address quality and compliance risks. • Serve as an advisor to executive teams and technical leads on regulatory pathways, submission strategies, and lifecycle management. • Provide project leadership and mentoring to junior team members, ensuring structured execution and high-quality deliverables. • Prepare and deliver client-facing reports, technical documentation, strategic recommendations, and training. • Support change management, technology transfer, and scale-up initiatives for manufacturing and operations. • Travel to client sites as needed for assessments, workshops, audits, and project execution. Qualifications Required • 15+ years of progressively responsible experience in GxP environments within pharma, biotech, medical devices, or life sciences manufacturing. • Recognized subject matter expertise in at least one of the following domains: • 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 working knowledge of global GxP regulations and standards (FDA 21 CFR, EU MDR/IVDR, ISO 13485, ICH Q-series, GAMP 5, ISO 9001/62304/17025, etc.). • Proven ability to lead cross-functional projects and serve as a senior advisor for complex technical challenges. • Prior experience in consulting, advisory, or client-facing technical leadership roles. • Excellent communication, documentation, and presentation skills. Preferred • Advanced degree in Life Sciences, Engineering, Quality, Regulatory, or related field. • Previous work with both large multinational organizations and small/emerging companies. • Experience navigating regulatory submissions (510(k), PMA, NDA, BLA, IND, Technical Files). • Professional certifications such as: • ASQ (CQE, CQA, CMQ/OE) • RAC (Regulatory Affairs Certification) • PMP • Six Sigma Green/Black Belt Engagement Type This is a consulting/contract-based role. Engagements vary by project and may include: • Full-time project support • Part-time advisory • Fixed deliverable-based engagements • Remote, hybrid, or on-site work depending on client needs Please note: We are currently building our database for GxP Consultants. Once we have active requisitions that align with your expertise, we will reach out to discuss potential opportunities. Apply tot his job