Lead GxP-focused consulting projects, develop and optimize Quality Management Systems, support compliance readiness, mentor junior members, and provide expert regulatory advice.
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
- Process 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.
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)
- Quality Assurance / Quality Systems
- 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.
- 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
- ASQ (CQE, CQA, CMQ/OE)
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
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