GxP Senior Consultant / Subject Matter Expert
New
United StatesContractSenior
Salary not disclosed
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Job Details
- Experience
- 15+ years
- Required Skills
- Quality AssuranceRisk Management
Requirements
- 15+ years of experience in GxP environments within pharma, biotech, medical devices, or life sciences.
- Recognized subject matter expertise in Quality Assurance, Regulatory Affairs, Validation, or Engineering.
- Working knowledge of global GxP regulations (FDA 21 CFR, EU MDR, ISO 13485, ICH Q-series, GAMP 5).
- Proven ability to lead cross-functional projects.
- Prior experience in consulting or client-facing technical leadership roles.
- Excellent communication, documentation, and presentation skills.
Responsibilities
- Lead and deliver GxP-focused consulting engagements.
- Develop, review, and optimize Quality Management Systems (QMS) and regulatory frameworks.
- Provide expert guidance on compliance readiness and responses to regulatory inspections.
- Design, execute, and oversee validation and qualification programs.
- Support product development programs ensuring adherence to design control and risk management.
- Perform gap assessments, root cause investigations, and CAPA development.
- Serve as an advisor to executive teams and technical leads.
- Provide project leadership and mentoring to junior team members.
- Prepare and deliver client-facing reports and technical documentation.
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