Quality Site Lead - Kentucky Distribution Center

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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 Quality Site Lead manages 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 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.

* Provide quality and compliance oversight for commercial and clinical distribution activities at the Kentucky Distribution Center (KDC). Ensure operations are suitable and effective to meet customer needs, regulatory requirements, industry trends and the company's quality & compliance objectives.
* Manage a team of approximately 5-10 members, responsible for GxP quality oversight, inspection readiness, early escalation of compliance gaps and risks, and appropriate action for proactive mitigation.
* Reporting to the Head of Distribution Quality, part of the Distribution Quality Leadership Team which oversees distribution quality and compliance for the entire Roche/Genentech supply chain.
* As a member of KDC Site Leadership Team, ensures that a high performing Quality team supports business priorities. Liaises with other leaders on site as a key stakeholder and Quality representative.
* Secure KDC's "Right to Operate" by implementing a customer-oriented lean end-to-end mindset. Maintain a suitable Quality Culture based on robust quality acumen and a strong speak-up culture throughout at the site.
* Sustain quality oversight of KDC operations and deploy resources as needed. Maintain access and proficiency for all quality workflows owned by KDC-Q to ensure continuity and coverage.
* Ensure timely and thorough identification and communication of compliance gaps or risks.
* Meet enterprise needs by sharing resources and objectives with other leaders in
Distribution Quality, or other Roche/Genentech teams as appropriate to deliver to the PT vision and goals.
* Lead or effectively delegate leadership of special projects important for KDC quality and compliance.
* Accountable for establishing and conducting appropriate Quality Governance within KDC (e.g. Quality Council, Business Management Reviews, Management Review of Quality (MRoQ), etc.).
* Collaborate with other leaders and stakeholders to meet and adapt to both current and future needs of the Chapter and organization (skills, capabilities, technologies, etc.).
* Responsible for team member professional development. Manage all aspects of people processes related to the employee lifecycle. This includes the selection, hiring and capability building and training of personnel on the company and department systems and processes.
* Responsible for ongoing transport release of commercial batches and/or of IMPs (i.e. investigational medicinal products) at KDC.
* Chair of Quality Review Board for distribution related investigations or other quality issues at KDC.Coach team members to drive resolution of deviations and issues, maintaining a consistent state of full compliance and inspection-readiness.
* May participate in compiling, reviewing and approving of Pharma Quality System (PQS) standards and local procedures, ensuring that the standards are in compliance with applicable regulations and other HA requirements.

* B.A. or B.S. degree in life sciences, Pharmacy or a related scientific discipline.
* 5 or more years experience in the Pharma/Biopharmaceutical industry with significant expertise working in Quality, Compliance, Regulatory, Validation and/or related operations.
* Fundamental understanding of quality assurance concepts including Good
Manufacturing Practices (cGMP) and Good Storage and Distribution Practices (GSDP).
* Experience in multiple manufacturing technologies and product lifecycles is desirable.
* Strong creative leadership skills according to the Visionary, Architect, Catalyst, Coach (VACC) model, collaboration and coaching skills with proven ability to build robust and empowered teams.
* Solid communication skills and ability to influence at all levels.
* Travel up to 25% (domestic and international), though typically much less.

This position is not eligible for relocation support.

The expected salary range for this position based on the primary location of Kentucky is $132,000 to $245,200. 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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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