We are seeking a Project Manager to lead strategic projects with site impact, ensuring new product launches meet contract goals. The role includes managing cross‑functional teams, driving cost, schedule, and technical performance, establishing milestones, and ensuring successful execution of new product and value improvement initiatives.
Key Responsibilities:
- Define project goals, scope, resource and cost estimates, timeline, and risks. Facilitate cross-functional discussions to develop project proposals.
- Manage large, multi-project, multi-site cross-functional teams; provide performance input; foster strong alignment.
- Oversee VIP initiatives; identify, communicate, and manage risks.
- Lead initiation, planning, execution, control, and close-out activities; ensure team ownership of plans, schedules, and budgets.
- Ensure activities follow established processes; maintain documentation discipline; reinforce VIP and NPE best practices.
- Drive cross-functional communication; serve as liaison between teams and leadership; lead phase reviews; maintain documentation including minutes, issue logs, and metrics.
- Implement NPE methods; manage NPE risks and deliverables.
Experience Requirements:
- 5–7+ years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry (medical devices, pharmaceuticals, biotechnology, diagnostics, or similar).
- Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
- Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and process validation.
- Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems.
- Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.
- Familiarity with controlled documentation systems, engineering change processes, and manufacturing readiness requirements.
- Experience ensuring compliance with quality system procedures and regulatory expectations across the project lifecycle.
- PMP Certification is strongly recommended.
Quality System Requirements:
- Demonstrate a primary commitment to patient safety and product quality by adhering to applicable quality policies, procedures, and requirements.
- Ensure adequate resources (personnel, tools, etc.) are in place to support quality compliance and promote a work environment aligned with quality expectations.
Role Expectations:
- Applies in-depth conceptual, practical, and technical knowledge; understands related functions.
- Applies knowledge of key business drivers and cross-team integration to achieve objectives.
- Provides guidance, coaching, and may lead smaller projects or sub-projects with manageable risk.
- Solves problems of varying complexity; adapts or develops solutions using judgment and experience.
- Influences project, operational, or service activity effectiveness.
- Communicates complex information clearly; persuades and guides stakeholders in cross-functional settings.