Sr Manager, Quality Engineering

米国 - カリフォルニア - フォスターシティ品質保証正社員

Key Responsibilities

Own and maintain Global Quality project portfolios, ensuring visibility, alignment, and execution across the network.
Monitor project progress, proactively manage risks and dependencies, and ensure initiatives are delivered on time and within scope.
Drive end‑to‑end planning and execution of global quality initiatives, including detailed project plans, timelines, milestones, and resource management.
Collaborate closely with Project Leads and Quality Leadership to track progress, manage risks, and communicate outcomes across the organization.

Capture, prioritize, and manage Quality Systems enhancements and platform integrations, ensuring timely and effective implementation.
Support the annual Quality Planning process, ensuring alignment with corporate objectives and enterprise priorities.
Develop, organize, and maintain comprehensive QA and QC project documentation, dashboards, and performance reporting.

Facilitate regular project updates, steering committee meetings, quality forums, and executive‑level reporting.
Measure Quality project performance using appropriate systems, tools, and methodologies, including defining and tracking KPIs related to project success, quality impact, and operational outcomes.
Leverage data‑driven insights to inform decision‑making and drive continuous improvement.

Perform and assess project and quality risk management, escalating critical risks and mitigation strategies to leadership as needed.
Identify and implement opportunities for process efficiency, automation, and innovation across Quality initiatives.
Apply Organizational Change Management (OCM) strategies, as appropriate, to support adoption, sustainability, and business readiness.

Manage stakeholder relationships across all phases of the project lifecycle, engaging effectively with global, cross‑functional partners.
Guide and mentor junior Quality staff, fostering a culture of quality excellence, accountability, and continuous improvement.
Stay current on industry trends, regulatory changes, and best practices to proactively enhance Quality systems and processes.

Strong knowledge of Quality Systems, Quality principles, industry standards, and best practices.
Excellent problem‑solving, analytical, and attention‑to‑detail skills.
Strong written and verbal communication skills, with the ability to present clearly to senior and executive audiences.
Demonstrated strength in planning, prioritization, and managing multiple initiatives simultaneously.
Familiarity with project management tools, stakeholder management practices, and performance tracking methodologies.
Proven ability to engage and influence internal and external stakeholders, facilitate discussions, delegate effectively, and drive accountability.
Self‑motivated, proactive, highly organized, and results‑oriented with a strong sense of urgency.
Ability to navigate ambiguity and translate complex initiatives into clear, actionable execution plans.
Comfortable balancing competing priorities in a fast‑paced environment while fostering a collaborative, trust‑based culture.
PMP and/or Lean Six Sigma Green Belt certification is a plus.

Bachelor’s degree in a science‑related field (e.g., Life Sciences, Engineering, Chemistry, Biology, or related discipline).
At least 8 years of relevant industry experience in Quality, Quality Systems, Project Management, or regulated environments

Master’s degree in a related field with at least 6 years of relevant industry experience.

Advanced degree in a science, engineering, or quality‑related discipline.
Demonstrated experience managing global Quality projects or portfolios in regulated pharmaceutical, biotech, or medical device environments.
Experience supporting Quality Systems, QA/QC initiatives, and cross‑functional quality transformations.
Familiarity with project governance, executive reporting, and KPI‑driven performance management.
Project Management Professional (PMP) and/or Lean Six Sigma Green Belt certification.