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