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.
ESSENTIAL DUTIES AND 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.
This role has no direct managerial responsibilities but may make recommendations on hiring, training, scheduling, and mentoring.
KNOWLEDGE, SKILLS, AND ABILITIES- 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.
Knowledge of SAP inventory system beneficial and preferred.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least April 13, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $93,760.00 - $146,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: 10% of the TimeShift: DayDuration: No End DateJob Function: Quality/RegulatoryTop Skills
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