Job Information
Genentech, Inc. Global Quality Manager in Louisville, Kentucky
The Position
About the role, and the Quality team at KDC
Genentech is in business for life. Every day, patients all over the world are helped by medicines that the Pharma Global Technical Operations (PT) organization manufactures and distributes. Ensuring that every single dose meets the expectations and standards for safe usage is the primary focus of our global Quality organization, and our Quality team at the Kentucky Distribution Center (KDC) completes the final steps before products can be delivered to patients.
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).
This position is not eligible for relocation support.
The expected salary range for this position based on the primary location of Kentucky is $96,200 to $178,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on r ace, color, r eligion, gender, s exual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
Roche is an Equal Opportunity Employer & prohibits unlawful discrimination based on r ace, color, r eligion, gender, s exual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
