GxP Supplier Quality Manager

TL;DR

GxP Supplier Quality Manager (GxP/cGMP): Drive compliance excellence across external supplier networks and safeguard product quality throughout the supply chain with an accent on supplier regulatory compliance, quality due diligence, and enterprise-wide quality leadership. Focus on managing supplier quality activities end-to-end (selection through decommissioning), sustaining Quality Agreements, and ensuring strict cGMP compliance through audits, investigations, and regulatory submissions.

Location: Holly Springs, North Carolina, United States of America

Salary: $94,000–$174,600 (annual)

Company

hirify.global, a member of the Roche group, develops medicines through groundbreaking biotechnology research.

What you will do

• Oversee supplier quality activities from supplier 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, monitoring compliance and addressing deviations or gaps.
• Manage critical quality functions for product release, including batch review, investigation resolution, and change assessment under strict cGMP compliance.
• Ensure manufacturing processes, specifications, and analytical methods remain validated and regulatory-compliant through collaboration with suppliers.
• Develop and maintain quality risk management plans to identify and mitigate supplier compliance risks and drive continuous operational excellence.
• Support strategic initiatives such as quality due diligence for business development and represent Quality on early-stage Technical Development Teams.

Requirements

• Bachelor’s degree in life sciences, pharmaceutical sciences, chemistry, or equivalent experience.
• At least 5 years of industry experience with direct expertise managing external suppliers and supplier quality management/compliance.
• Comprehensive knowledge of cGMP, ISO standards, and international pharmaceutical regulations, with ability to interpret and apply them to supplier environments.
• Fluent oral and written English.
• Proficiency with standard office tools (Microsoft Office or Google Suite).
• Available for occasional domestic or international travel (up to 10% annually) for audits and on-site quality oversight.

Culture & Benefits

• Discretionary annual bonus may be available based on individual and company performance.
• Benefits available per the company benefits program.
• High-accountability, fast-paced environment focused on operational excellence.
• Equal opportunity employer.

Hiring process

• Application review followed by interviews and evaluation of quality/compliance experience.
• Final steps may include discussions focused on regulatory and supplier quality expertise.