Job Details

Position Title: Principal Project Manager
Work Location: South San Francisco, CA,94080
Assignment Duration: 8 Months
Work Schedule: 7 AM - 4 PM PST ( 1 hour lunch break)
Work Arrangement: Onsite

Position Summary

This is a high-impact, dual-focus contract role, requiring deep experience in the Medical Device and Combination Product industry.The role serves two key functions: operating as a Project Manager to drive the complex development program timeline execution, and acting as the QMS Specialist to ensure compliance with Client's Quality Systems.

Background & Context

This role is critical to ensuring successful execution of complex medical device and combination product programs through strong project management discipline and detailed timeline oversight.

Key Responsibilities

• Strategic Planning: Translate device strategy into actionable plans, defining "inspection-ready" Design & Development Plans.
• End-to-End Management: Lead a range of projects including development pipelines, line extensions, and technology initiatives.
• Team Performance: Foster high-performing team dynamics, facilitating efficient decision-making, issue resolution, and cross-functional collaboration.
• Governance & Business Gates: Navigate teams through business process stage-gates and support technical advisory or governance committee reviews.
• QMS Implementation: Drive implementation, maintenance, and continuous improvement of the Quality Management System (QMS) including the tracking of metrics
• Records Management: Manage Design History Files (DHF) and document repositories to ensure accuracy, completeness, and regulatory compliance.
• Audit Readiness: Manages audit and inspection readiness, including preparation for internal audits and Health Authority inspections, and oversees timely remediation of findings.
• Risk Mitigation: Proactively identify project and compliance risks, developing robust contingency and mitigation plans.
• Process Excellence: Lead business process continuous improvement initiatives by applying lessons learned and optimizing PM tools.
• Budget & Resources: Forecast and monitor team resources, project costs, and budget tracking.

Qualification & Experience

• Education: B.S. degree in Engineering, Technical Field, or a related discipline.
• Experience: At least 12 years in the Pharmaceutical or Medical Device industry.
• Minimum 5-6 years specifically in devices or combination products.
• Proven experience in drug/device development and commercialization.
• Regulatory Expertise: Extensive knowledge of EU MDR, FDA 21 CFR Parts 210, 211, & 820 (including 820.30 design controls), and ISO 13485.
• Project Management: Proficiency in PM best practices and software; PMP certification is considered a significant asset.
• Leadership: Excellent professional presence with the ability to interact at all organizational levels and work with little to no supervision.