GxP Supplier Quality Manager

Genentech•Holly Springs, NC

2d•Onsite

About The Position

Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028. At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. As a Quality Assurance Specialist -Supplier Quality, you will drive compliance excellence across our external supplier (Direct Materials and Service Providers) network and safeguard product quality throughout the supply chain. This versatile role offers the unique opportunity to combine hands-on supplier oversight with enterprise-wide quality leadership, including strategic initiatives like quality due diligence and early-stage program support. You will serve as a trusted expert in Suppliers’ regulatory compliance and operational excellence, directly impacting our mission to deliver safe, high-quality products to patients.

Requirements

Bachelor's degree in life sciences, pharmaceutical sciences, chemistry, or equivalent professional experience demonstrating comparable knowledge in a related industry.
Demonstrated experience managing supplier and service provider relationships.
At least 5 years of industry experience, with direct expertise in managing external suppliers and a deep understanding of supplier quality management and compliance.
Comprehensive knowledge of cGMP, ISO standards, and international pharmaceutical regulations, with a proven ability to interpret and apply these standards to supplier environments.
Excellent communication skills (fluent in oral and written English) to articulate complex quality concepts clearly to diverse audiences.
Proficiency with standard office tools (Microsoft Office or Google Suite).
Available for occasional domestic or international travel (up to 10% annually) to conduct audits and oversee quality on-site.

Responsibilities

Oversee quality activities from supplier (Direct Materials and Service Providers) selection through decommissioning, including process validations, audits, Health Authority inspections, investigations, and regulatory submissions.
Create, negotiate, and sustain Quality Agreements with external suppliers and partners, rigorously monitoring compliance and addressing any deviations or gaps.
Manage critical quality functions for product release, such as batch review, investigation resolution, and change assessment, ensuring strict cGMP compliance.
Collaborate with external suppliers to keep manufacturing processes, specifications, and analytical methods in a validated, regulatory-compliant state.
Develop and maintain quality risk management plans to proactively identify and mitigate supplier compliance risks while driving continuous operational excellence.
Expand your impact through strategic initiatives, such as conducting quality due diligence for business development and representing Quality on early-stage Technical Development Teams.
Build strong relationships across internal and external partners to align quality expectations and quickly drive the interdepartmental resolution of complex regulatory challenges.