Description:
The Global Quality Manager, Distribution Quality position is a senior operational role in the Quality team at KDC, Genentech’s North American logistics and distribution hub. The KDC Quality team is part of the global Distribution Quality chapter in External Quality, and one of the team’s critical responsibilities is to provide the final confirmation that Genentech’s internally and externally (CMO) manufactured life-saving products comply with Quality requirements before being released to patients via distributors and hospitals. This role proactively supports and provides matrix leadership to the other members of the Quality team, and is a key member of the site Leadership Team that is focused on strengthening a foundation of quantitative continuous improvement. In addition to the operations/distribution aspects of this role, other elements include being the single point of contact for multiple Genentech Quality systems, ensuring site commercial and clinical supply distribution operations and contractors comply with cGMPs, cGDPs, Quality Agreements and providing input in the systemic evolution of Genentech’s ERP system.
The ideal candidate:
- Prioritizes and delivers value-driven outcomes, both as an individual and organizationally. Has a strong business acumen, evaluates opportunities for quantifiable value creation and waste reduction in effort/benefit terms.
- Is a catalyst for positive change and has experience in organizations where robust and complex processes were the foundation upon which a continuous improvement framework was built. Can concisely summarize the key structural/cultural elements and the leadership/team dynamics that supported the continuous improvement outcomes, as well as those that hindered success.
- Deeply understands the systemic nature of Lean Production System (LPS) principles and process improvement. Has experienced successful network-level LPS deployment to deliver significant value/efficiency. Inclusively seeks to catalyze others to join such efforts, understands the human element of mindset change as a complement to process change. Uses the power of process visualization to drive outcomes.
- Has good technical decision-making skills, and can troubleshoot and resolve complex issues. Deep experience in Root Cause Analysis (RCA) and effective CAPA deployment.
- Is naturally curious and seeks to understand. Would not be deterred by lacking background knowledge from asking questions in a discussion among a group of subject matter experts. Willing to examine and challenge existing processes to find potential for improvement.
- Communicates effectively. Can easily summarize the key elements of a situation, topic or decision and deliver appropriate messages to different audiences such as senior leaders, stakeholders, teammates and operators. Demonstrates empathy and good listening skills.
- Seeks opportunities to collaborate and more effectively integrate with other parts of the KDC operation, the global Distribution Quality chapter based in Switzerland and stakeholders.
- Promotes a culture of trust, collaboration, feedback and speaking up by modeling desired behavior.
- Main responsibilities: Ensure the Quality oversight and inspection readiness of the KDC warehousing and distribution operations; perform Quality operational activities to enable the compliant and efficient release and distribution of products to the market and clinical sites; maintain and continuously improve the Quality system; drive or contribute to continuous improvement initiatives across the Global Distribution Quality scope.
Who you are:
- Bachelor’s degree in engineering, life sciences or other science/technical fields preferred; master’s degree/PhD is a plus.
- 10+ years of professional experience in strong global quality- or process-related environments
- Well-developed people skills; effective at influencing and motivating without direct reporting authority. Strong mentoring experience and use of effective coaching skills to empower colleagues.
- Familiar with business/ERP systems that support processes (e.g. SAP, TrackWise, Veeva).