Quality Compliance

Agilent Technologies • Frederick, MD

2d

About The Position

This position provides strategic Quality Assurance (QA) oversight to support Agilent’s expanding and diversified client portfolio while maintaining a strong internal compliance posture. The role consolidates audit and regulatory responsibilities into a unified function that ensures inspection readiness, regulatory alignment, and operational oversight across internal systems and client-facing engagements. Individuals in this position may act as delegates for each other.

Requirements

• Strong knowledge of GMP guidelines and international pharmaceutical regulations.
• Experience in conducting internal audits and facilitating external client audits in a regulated environment.
• Ability to interpret and apply regulatory requirements to QMS processes and documentation.
• Excellent written and verbal communication skills for audit coordination and regulatory discussions.
• Advanced problem-solving and analytical skills to identify compliance risks and drive corrective actions.
• Ability to write audit reports, business correspondence, and procedures.
• Skill in leading cross-functional initiatives and managing multiple priorities.
• Proficiency in Microsoft Office and other relevant software tools.
• Bachelor's or Master's Degree or equivalent. Post-graduate, certification and/or license may be required.
• 4+ years relevant experience in supplier management related experience; or equivalent combination of education and experience.
• Prior experience and/or training working in a GMP production environment is required.

Nice To Haves

• Knowledge of SAP inventory system beneficial and preferred.

Responsibilities

• Leads and executes the internal self-inspection program , including scheduling, conducting audits, and managing follow-up activities to drive continuous improvement of the Quality Management System (QMS).
• Performs internal audits to assess compliance with applicable regulatory requirements and internal procedures, ensuring inspection readiness and proactive risk mitigation.
• Facilitates external client audits , managing logistics, providing real-time support, and coordinating post-audit responses and CAPA implementation.
• Conducts regulatory gap assessments to ensure the QMS remains aligned with current and emerging pharmaceutical/GMP regulations.
• Supports cross-functional teams with regulatory interpretation , risk assessments, and inspection preparedness activities.
• Collaborates with internal stakeholders to ensure audit findings are addressed effectively and that systemic improvements are implemented.
• Develops and maintains audit-related documentation, including audit plans, reports, CAPA tracking, and regulatory alignment summaries.
• Assists with client and regulatory inspections as requested by management.
• Participates in internal quality initiatives and supports the development of scalable compliance operations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level