Director, Head of Audit & Compliance Operations

The Director, Head of Audit & Compliance Operations within Global Quality Compliance & Systems (QCS) provides strategic direction, leadership, and oversight of inspection readiness, inspection management, and compliance operations for Agilent. Reporting to the AVP of Compliance in QCS, this individual plays a decisive role in maintaining and continually improving Agilent's framework for inspection/external audit readiness, inspection management and follow-up, and internal audits in the regulated space, including supporting business processes, tools, systems and governance. In addition, Compliance Operations liaises with Agilent groups/divisions and sites on compliance-relevant topics and sustainably resolves issues across the network. The latter aspect plays a key role in building the bridge between the platform QCS team and the sites/divisions, maintaining, and continually improving Agilent's compliance posture, and providing hands-on operational quality support with compliance processes and related governance. This includes but is not limited to corrective and preventative action (CAPA), investigations into systemic or complex issues, and remediation activities.

Key responsibilities include:

Management of external audits/inspections:

• Develop a risk-based Health Authority/Regulatory inspection and Registrar/Notified Body audit readiness strategy and framework, and oversee, monitor, and continually improve its execution across Agilent.

• Develop, implement, and continually improve processes, systems and tools defining the inspection management framework, including preparation, execution, response management, inspection follow-up, and governance.

• Partner with the Business Quality groups during inspection/audit readiness, execution/management and follow-up to ensure successful outcomes for Agilent.

• Drive activities to ensure a state of continuous inspection readiness for regulatory inspections and external audits within Agilent including the development and execution of strategic and tactical internal audit plans.

• Manage and oversee external inspection/audits of Agilent across disciplines (ISO, MDSAP, IVDR, FDA and other regulatory authorities). Lead inspection readiness and management activities for assigned high-impact audits/inspections, including identification and engagement of SMEs for participation

• Evaluate proposed inspection commitments in response to inspection findings. Ensure that all commitments are met on time and in full. Implement proactive CAPA tracking and confirm their timely closure.

• Routinely evaluate outcomes of regulatory inspections, identify trends/best practices, and conduct lessons learned sessions to ensure identified process improvement opportunities are swiftly and sustainably implemented.

Regulated Internal Audit Program:

• Lead and project manage the end-to-end regulated internal audit program across Agilent, encompassing risk-based identification of targets, audit preparation and scheduling, audit planning, conduct, and response/follow-up.

• Provide regular reports to Agilent GQRA leadership on the status of the internal audit program, regulatory inspection readiness and CAPA commitments on a program and portfolio level. Participate in and support Management Reviews with Agilent Executive Leadership.

• Ensure coverage of the entire Agilent portfolio, including ISO 9001, ISO 13485/IVDR and cGMP CDMO/CMO sites.

• Establish, maintain and continually enhance a network of strategic third-party audit partners to support audit activities as required, particularly in specialized areas, e.g., GCP or GVP.

Compliance Operations:

• Promote process excellence, consistency, and harmonization for QMS elements pertaining to inspection/audit management, internal audits, the CAPA program, and quality investigations.

• Support the development and implementation of robust corrective and preventive actions in response to audits/inspections, based on trends and systemic issues.

• Identify, maintain, and manage overall compliance activities across Business Groups and at the Agilent level to promote a state of compliance. Drive CAPA and effectiveness check requirements and improvements, in partnership with applicable Business Quality groups, and ensure complex and systemic issues are addressed promptly and sustainably.

• Support Agilent sites/divisions with adhering to the Agilent QMS and applicable regulatory requirements and standards and promote overall compliance posture.

• Serve as a Subject Matter Expert for Quality & Compliance related issues, lead and/or support complex investigations and drive risk-based actions, issue resolution and continual improvement across the network.

• Lead/support relevant processes and fora (e.g., Community of Practices, SME networks) that help drive upskilling and capability building across the organization.

Team leadership:

• Serve as a strategic thought partner to the VP of Quality Compliance & Systems, the AVP of Compliance and other senior executives with regard to complex problems and the future strategies of regulatory inspection management for Agilent, and the regulated internal audit program.

• Direct and manage the global Audit & Compliance Operations team within QCS Compliance by leading a group of Compliance professionals supporting Agilent sites/divisions with a broad spectrum of Quality Operations support (CAPA, inspection/audit readiness, complex/systemic investigations, remediation, audit, response management).

• Lead Talent Management (recruiting, hiring, termination, organizational design, performance management, talent/leadership development) for the global Audit & Compliance Operations team.

• Education: Bachelor's degree of science or related field is required, advanced degree in engineering, pharmaceutical or scientific field preferred (MSc, PhD).

• 10+ years of industry experience, with increasing managerial responsibility and matrix leadership in the life science environment (medical device/diagnostics/biopharma).

• Experience must include 5+ years of experience with managing inspections and audits, conducting/leading audits, regulatory compliance, supplier quality management, etc., in a life science, medical device, or pharmaceutical environment, and 5+ years relevant experience in managing diverse, global teams.

• Demonstrated experience with managing audits/inspections under ISO 9001, ISO 13485, MDSAP, IVDR, 21 CFR 820, 21 CFR 210/211, 21 CFR Part 11. Additional experience in the biopharmaceutical environment, ISO 27001, ISO 17025, ISO 17034, ICH guidelines a plus.

• Demonstrated ability to interface with senior executives and cross-functional teams, and strong proven ability to influence and drive change.

• Strong leadership and team building skills.

• Experience in managing complex organizational challenges and identifying and successfully implementing corporate-level strategic initiatives and priorities.

• Demonstrated ability to effectively manage multiple priorities with a sense of urgency.

• Experience in operating in a multi-disciplinary life science environment.

• Excellent written and verbal communication skills.

• Fluency in written and spoken English.

Additional Details