Key Responsibilities

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  Lead and deliver GxP-focused consulting engagements, serving as an SME across multiple functions such as Quality, Regulatory, Manufacturing, Engineering, and Clinical Operations.
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  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.).
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  Provide expert guidance on compliance readiness, remediation, and responses to regulatory inspections (FDA 483s, Warning Letters, audit observations).
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  Design, execute, and oversee validation and qualification programs:
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    Process validation
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    Equipment qualification (IQ/OQ/PQ)
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    Software/CSV (21 CFR Part 11)
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    Cleaning and sterilization validation
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    Computerized systems validation
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  Support product development programs, ensuring adherence to design control, risk management, verification/validation, and DHF/technical documentation requirements.
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  Perform gap assessments, root cause investigations, and CAPA development to address quality and compliance risks.
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  Serve as an advisor to executive teams and technical leads on regulatory pathways, submission strategies, and lifecycle management.
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  Provide project leadership and mentoring to junior team members, ensuring structured execution and high-quality deliverables.
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  Prepare and deliver client-facing reports, technical documentation, strategic recommendations, and training.
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  Support change management, technology transfer, and scale-up initiatives for manufacturing and operations.
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  Travel to client sites as needed for assessments, workshops, audits, and project execution.

Qualifications

Required

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  15+ years of progressively responsible experience
  in GxP environments within pharma, biotech, medical devices, or life sciences manufacturing.
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  Recognized subject matter expertise in at least one of the following domains:
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    Quality Assurance / Quality Systems
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    Regulatory Affairs
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    Validation & Engineering (Process, Equipment, Automation, CSV)
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    Manufacturing Operations / Tech Transfer
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    Clinical Operations & Compliance
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    Risk Management (ISO 14971)
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    Design Controls (21 CFR 820, ISO 13485)
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  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.).
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  Proven ability to lead cross-functional projects and serve as a senior advisor for complex technical challenges.
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  Prior experience in consulting, advisory, or client-facing technical leadership roles.
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  Excellent communication, documentation, and presentation skills.

Preferred

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  Advanced degree in Life Sciences, Engineering, Quality, Regulatory, or related field.
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  Previous work with both large multinational organizations and small/emerging companies.
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  Experience navigating regulatory submissions (510(k), PMA, NDA, BLA, IND, Technical Files).
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  Professional certifications such as:
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    ASQ (CQE, CQA, CMQ/OE)
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    RAC (Regulatory Affairs Certification)
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    PMP
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    Six Sigma Green/Black Belt

Engagement Type

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  Full-time project support
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  Part-time advisory
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  Fixed deliverable-based engagements
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  Remote, hybrid, or on-site work depending on client needs