Strategy Lead, Global Device Quality (South San Francisco)

Need local candidate to South San Francisco, California

This role is based in the Global Device Quality Management organization which has the end-to-end responsibility of leading and managing the quality aspects of developing medical devices, drug-device combination products, packaging to deliver the pharmaceutical pipeline and handling complaints to improve customer experience and supporting industrialization. We provide oversight for the development, implementation, and continuous improvement of device-related quality processes and procedures as well as technical and compliance guidance considering the relevant standards and regulatory requirements for medical devices, combination products and packaging.

We work closely with device development and device lifecycle teams during development and manufacturing to ensure product integrity to design and manufacturing process specifications. We leverage our external partners in order to offer flexibility and know-how to our internal capacity, at the right cost and quality.

We enable our partners to reliably deliver compliant, quality products to our supply chain customers, so that we can meet the needs of patients worldwide.

We accomplish our mission through cross-functional collaboration focused on continuous improvement, embedding quality and reliability into the design, and ensuring quality process excellence.

The Opportunity

As an integral part of Global Device Quality Management, the strategic advisor for

Device Quality will play a critical role in driving strategic initiatives, enhancing

operational excellence, and fostering cross-functional collaboration within the Quality

and Device organization. This individual will serve as a key advisor to senior leadership, ensuring alignment across teams, optimizing processes, and facilitating decision-making to strengthen device quality, compliance, and regulatory readiness.

Partner with senior leadership to define and execute strategic priorities for pharma device quality, ensuring alignment with corporate objectives.

Act as a thought leader in device quality management, risk mitigation, compliance strategies, supplier management, complaints handling, and quality management systems

Serve as a liaison between the device quality leadership team and internal / external stakeholders, ensuring effective communication and alignment.

Prepare high-level presentations, reports, and executive summaries for senior management and board-level discussions.

Facilitate leadership meetings, strategic planning sessions, and cross-functional working groups.

Oversee critical business processes, identify areas for improvement and implement best practices to enhance efficiency and compliance.

Facilitate cross-functional collaboration between quality, device, regulatory, packaging, complaints, manufacturing, and commercial teams.

Develop and implement dashboards, KPIs, and reporting mechanisms to track program performance and organizational effectiveness in device quality.

Support leadership in ensuring adherence to FDA, EMA, and other global regulatory requirements for combination products.

Partner with quality, device and regulatory teams to manage audits, inspections, and remediation efforts.

Provide mentorship and support talent development within the device quality team to foster a high-performance culture focused on continuous improvement.

Who you are

• You are someone who wants to influence your own development and can work independently, with limited supervision. You seek a company where you have the opportunity to pursue your interests across functions and geographies- where a job title is not considered the final definition of who you are, but the starting point.
• You have a degree in an Engineering or Science discipline and bring 8+ years of experience in pharmaceutical, biotech, or device quality, with a strong understanding of global regulations. You have a solid understand of the biotechnology industry, particularly in combination products and medical devices.
• You have experience in leadership, project management, or strategy rolesuch as quality leadership, program management, or corporate strategy. You have the ability to lead cross-functional teams and drive organizational change. You can manage multiple projects and priorities in a dynamic environment.
• You possess exceptional communication skills for executive-level presentations and reporting. You have a strong ability to influence senior leadership and drive decision-making. You can analyze complex quality and compliance challenges and develop actionable solutions.

Preferred

Ability to educate teams and organization on Design Controls as it applies to medical devices and combination products, and related topics

Demonstrated capability of applying risk management concepts and tools

Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing.

Fluency in English is a must

Experience in working in agile environment and usage of lean tools

ASQ CQE certification is a plus (but not required)

Proficiency in quality metrics, data visualization, and performance tracking (KPIs, dashboards, etc.)

Familiarity with audit preparation and management (internal, FDA, EMA, ISO, etc.).

This position requires up to 20% travel