GxP Senior Consultant – Subject Matter Expert, Life Sciences
Job Description:
• 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
Apply tot his job
Apply To this Job
• 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
Apply tot his job
Apply To this Job