Pharmavise Corporation

Business Development Rep

• Execute outbound outreach to Business Development (BD) leads
• Schedule discovery calls with prospective clients
• Maintain consistent follow-ups to maximize engagement and response rates
• Support movement of BD leads to qualified opportunities
• Assist in preparing briefing documents prior to discovery calls

Business Development Representative – Life Sciences Consulting

Consultant

• 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.

Business Development Representative – Life Sciences Consulting

GxP Senior Consultant – Subject Matter Expert