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. The Opportunity: • 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. Who You Are: • You hold a Bachelor's degree in life sciences, pharmaceutical sciences, chemistry, or have equivalent professional experience demonstrating comparable knowledge in a related industry. • Demonstrated experience managing supplier and service provider relationships is highly valued. • You bring at least 5 years of industry experience, with direct expertise in managing external suppliers and a deep understanding of supplier quality management and compliance. • You possess comprehensive knowledge of cGMP, ISO standards, and international pharmaceutical regulations, with a proven ability to interpret and apply these standards to supplier environments. • You are an excellent communicator (fluent in oral and written English) who can articulate complex quality concepts clearly to diverse audiences, from regulators to internal leadership. • You are proficient with standard office tools (Microsoft Office or Google Suite) and are available for occasional domestic or international travel (up to 10% annually) to conduct audits and oversee quality on-site. This position is not eligible for relocation support. The expected salary range for this position based on the primary location of Holly Springs, NC, is $94,000 to $174,600. 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 #LI-PK1