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

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