Principal Project Manager (276022)
20 hours ago
South San Francisco
Job Description "All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment". Job Title: Principal Project Manager Location: South San Francisco, CA , 94080 Duration: 8+ Months PR: $100 - $104.90 hr. On W2 Job Description: • Principal Project Manager (Contractor) 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 Quality Systems., • This role is critical to ensuring the successful execution of complex medical device and combination product programs through strong project management discipline and detailed timeline oversight., • The position combines end-to-end project planning and coordination with support for Quality Management System (QMS) activities, enabling alignment between program execution and regulatory expectations. In addition to driving integrated timelines, cross-functional coordination, and milestone delivery, the role supports QMS processes to help ensure that internal systems, documentation, and personnel qualifications meet global health authority requirements., • Project Management & Execution 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., • Compliance & Quality Management System Support 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., • Operations & Continuous Improvement 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., • 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., • Work Environment & Logistics Location: SSF Onsite role., • Travel: May travel once or twice a year with external partners and headquarters., • Flexibility: Ability to interact across global time zones as required and work during global hours (7 am - 10 am Pacific) Contract Duration: approx 8 Months (For 2026) About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.