Senior QA Specialist (Medical)

TL;DR

Senior QA Specialist (Medical): Providing quality oversight for Quality Control laboratory operations in a high-volume Drug Product manufacturing facility with an accent on GxP compliance, data integrity, and global regulatory standards. Focus on embedding Quality by Design into QC processes, leading complex investigations (CAPA), and managing the digital transformation of laboratory documentation.

Location: Onsite in Holly Springs, North Carolina, USA

Salary: $94,000 - $174,600

Company

hirify.global is a member of the Roche group and a pioneer in the biotechnology industry dedicated to discovering and developing medicines for people with serious and life-threatening diseases.

What you will do

• Provide quality oversight for analytical, microbiological, and operational data within state-of-the-art QC labs to ensure global regulatory compliance.
• Implement "Quality by Design" into QC processes, approving procedures, specifications, and methods to maximize efficiency.
• Lead complex investigations to determine root causes and implement effective Corrective and Preventive Actions (CAPA), moving beyond human error.
• Support commissioning, qualification, and regulatory inspections (FDA, EMA), including review and approval of dossier sections.
• Conduct periodic audit trail reviews, lab self-inspections, and Gemba walks.
• Act as the QA Owner for digital applications enabling the transformation from paper-based documentation to digital QC activities.

Requirements

• Bachelor’s degree in a scientific discipline; a graduate or higher-level degree is strongly preferred.
• Minimum 6–8 years of experience in a GxP environment, with at least 4 years of broad QC experience.
• Advanced knowledge of GMP and experience participating in global regulatory inspections (FDA, EMA).
• Expertise in QMS processes including deviation management, CAPA, and change control.
• Strong technical writing skills and a rigorous mindset regarding data integrity principles.
• Must be based in or able to work onsite in Holly Springs, North Carolina (Relocation funding is not available).

Culture & Benefits

• Opportunity to be a foundational pioneer in a $2B greenfield start-up facility launched from the ground-up.
• Fast-paced, entrepreneurial environment with high accountability and a focus on innovation.
• Access to next-generation technology, including advanced automation, robotics, and real-time data analytics.
• Discretionary annual bonus based on individual and company performance.
• Collaborative team culture within a company recognized on the Fortune 100 Best Companies to Work For list.