Senior Technical Manager External Quality

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 life-saving 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 Senior Technical Manager, External Quality position is an operational role in the Quality team at KDC, Genentech's primary North American logistics and distribution hub. This role is part of a globally connected team within the External Quality organization supporting the Genentech/Roche network of distribution and transportation activities. 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. Other responsibilities include ensuring site clinical and commercial supply distribution operations and contractors comply with cGMPs, cGDPs, Quality Agreements and providing input in the systemic evolution of Genentech's ERP system.

This includes but is not limited to the Quality oversight of:

• Clinical and commercial lot/batch release

• Distribution and transportation activities including the management, resolution and Product Quality impact assessment of deviation events during distribution and transportation of clinical and commercial products.

• Distribution centers (including 3PLs) and CWOs

• Assessment of change records

• Audit and inspection readiness in GMP/GDP clinical and commercial distribution operations

• Regulatory readiness activities required (including PQS and End-to End management of GMP documents) to ensure a regulatory compliant supply of clinical and commercial material.

• Qualification initiatives / projects

Who you are:

• Previous experience in pharmaceutical manufacturing, QA, management or supply chain. Experience with Quality systems (SAP, Veeva) and/or lot/batch release a plus.

• Quality mindset to collaborate with site partners

• Practices a service oriented mindset to serve the best interests of our patients, stakeholders and customers.

• Proactive thinking; open minded curiosity, eagerness to learn. Inclusive mindset.

• Strong business acumen and ability to prioritize value delivery. Familiarity with continuous improvement principles a strong plus.

• Well-developed problem solving skills, especially the area of root cause analysis and effective corrective actions

• Able to communicate clearly and professionally both in writing and verbally. Can summarize and prioritize information for efficient, effective messaging.

• Knowledge of current international Good Distribution/Manufacturing Practices and Quality Management ISO Standards.

• B.A. or B.S. degree in life sciences or engineering / equivalent, or relevant work experience.

• This position may require infrequent domestic travel.

This position is not eligible for relocation support.

The expected salary range for this position based on the primary location of Kentucky is $84,500 to $156,900.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 race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.