GxP Sr. Consultant / Subject Matter Expert
P
Pharmavise CorporationLife Sciences
United StatesContractSenior
Salary not disclosed
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Job Details
- Experience
- 15+ years
- Required Skills
- Quality AssuranceRisk Management
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 domain: Quality Assurance, Regulatory Affairs, Validation/Engineering, Manufacturing Operations, Clinical Operations, Risk Management, or Design Controls.
- 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).
- 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.
- Advanced degree in Life Sciences, Engineering, Quality, or Regulatory is preferred.
- Professional certifications such as ASQ (CQE, CQA, CMQ/OE), RAC, PMP, or Six Sigma are preferred.
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 global standards.
- Provide expert guidance on compliance readiness, remediation, and responses to regulatory inspections.
- Design, execute, and oversee validation and qualification programs, including process, equipment, and computerized systems validation.
- Support product development programs by ensuring adherence to design control, risk management, and 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 to ensure high-quality deliverables.
- Prepare and deliver client-facing reports, technical documentation, and strategic recommendations.
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