Pharmavise Corporation

GxP Senior Consultant – Subject Matter Expert, Life Sciences

Pharmavise Corporation

contract

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Job Level

Senior

About the role

  • 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.

Requirements

  • 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.
Benefits
  • Health insurance
  • Departmental retreats
  • Flexible working hours
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Quality Management Systems (QMS)regulatory frameworkscompliance readinessvalidation programsqualification programsProcess validationEquipment qualificationSoftware/CSVCleaning validationComputerized systems validation
Soft skills
project leadershipmentoringcommunicationdocumentationpresentationadvisorycross-functional collaborationstrategic recommendationsclient-facingchange management