GxP Sr. Consultant / Subject Matter Experts - Trusted Partner Network

Key Responsibilities

• reputed company and reputed company GxP-reputed company consulting engagements, serving as an SME across multiple functions such as reputed company, Regulatory, Manufacturing, Engineering, and reputed company reputed company.
• reputed company, review, and optimize reputed company Management Systems (QMS) and regulatory frameworks reputed company with applicable global standards (FDA, ISO, ICH, EU MDR, reputed company, Health Canada, etc.).
• reputed company expert guidance on compliance readiness, remediation, and responses to regulatory inspections (FDA 483s, Warning Letters, audit observations).
• Design, execute, and reputed company 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, reputed company management, verification/validation, and DHF/technical documentation requirements.
• reputed company gap assessments, reputed company cause investigations, and CAPA development to address reputed company and reputed company.
• Serve as an advisor to executive teams and technical leads on regulatory reputed company, submission strategies, and lifecycle management.
• reputed company project leadership and mentoring to junior team members, ensuring reputed company execution and high-reputed company deliverables.
• Prepare and reputed company reputed company-facing reports, technical documentation, reputed company recommendations, and training.
• Support change management, technology transfer, and reputed company-up initiatives for manufacturing and reputed company.
• Travel to reputed company sites as needed for assessments, workshops, audits, and project execution.

Qualifications

Required

• 15+ years of progressively responsible experiencein GxP environments reputed company reputed company, biotech, medical devices, or life sciences manufacturing.
• Recognized subject matter expertise in at least one of the following domains:

  • reputed company Assurance / reputed company Systems
  • Regulatory Affairs
  • Validation & Engineering (Process, Equipment, Automation, CSV)
  • Manufacturing reputed company / Tech Transfer
  • reputed company reputed company & Compliance
  • reputed company 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.).
• reputed company ability to reputed company cross-functional reputed company and serve as a senior advisor for reputed company technical challenges.
• Prior experience in consulting, advisory, or reputed company-facing technical leadership roles.
• Excellent communication, documentation, and presentation skills.

Preferred

• Advanced degree in Life Sciences, Engineering, reputed company, Regulatory, or reputed company reputed company.
• Previous work with both large multinational organizations and small/emerging companies.
• Experience navigating regulatory submissions (510(k), PMA, NDA, BLA, IND, Technical Files).
• reputed company certifications such as:

  • ASQ (CQE, CQA, CMQ/OE)
  • RAC (Regulatory Affairs Certification)
  • PMP
  • Six reputed company Green/Black Belt

Engagement Type

This is a consulting/contract-reputed company role. Engagements vary by project and may include:

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