Position Summary
The Regulatory Inspection Manager leads end-to-end management of regulatory inspections supporting Lincoln Operations, including the White Hall, IL site. These manufacturing sites produce sterile vaccines, monoclonal antibodies, and non-sterile pharmaceuticals for animal health. The role serves as the primary coordinator and point of contact with Health Authorities and in-country Zoetis Regulatory Managers, with primary inspection interfaces including the EU, FDA, and additional global markets as applicable. USDA interactions are coordinated through a dedicated USDA liaison. This role plans, prepares for, hosts, and drives closure of regulatory inspections to ensure compliant outcomes, timely commitments, and sustained inspection readiness. The role is manager-level and operates as an individual contributor (no direct reports), leveraging strong matrix leadership across site functions and above-site teams.
Hours: 1st Shift, 7:30am - 4:00pm.

Position Responsibilities
Regulatory inspection leadership (end-to-end)
● Own site regulatory inspection management from notification through closure.
● Partner directly with regulatory authorities to schedule inspections and align logistics, scope, and expectations (for USDA-related inspections, coordinate through the site's designated USDA liaison).
● Serve as the primary liaison between inspectors, the site, and in-country Zoetis Regulatory Managers; maintain clear, professional, and timely communication.
Inspection planning and readiness
● Develop inspection plans and timelines; coordinate cross-functional execution.
● Identify and organize the site inspection team (e.g., SMEs, document runners, escorts, room coordinators, leadership participants).
● Train and coach the inspection team on inspection conduct, communication, document handling, and escalation paths.
● Establish inspection agendas and daily schedules in collaboration with site leadership and relevant functions.
● Coordinate document retrieval, review, and readiness (including rapid turnaround during inspection).
● Ensure conference rooms and inspection areas are prepared (A/V, printing, secure document handling, access control, signage, hospitality/logistics as appropriate).
Inspection execution / hosting
● Lead on-site inspection coordination while inspections are in progress; adjust plans and resources as needed to keep the inspection running smoothly.
● Function as site host as needed, including managing daily openings/closings, coordinating escorts, and facilitating interactions with SMEs.
● Maintain real-time communication with site and above-site leadership regarding inspection status, requests, observations, and risk.
Post-inspection response and closure
● Coordinate communication with inspectors on receipt/clarification of the inspection report, as appropriate.
● Lead cross-functional development of responses with site SMEs and leadership (root cause, corrective actions, timelines, ownership).
● Draft and finalize formal inspection responses, ensuring technical accuracy, completeness, and alignment with Zoetis expectations.
● Build executive-ready presentations for above-site communication outlining observations, response strategy, and business impact (resources, expenses, capital as applicable).
● Track commitments to closure, ensuring deliverables are completed by committed dates; proactively escalate risks and delays.
● Communicate responses and progress to in-country Zoetis Regulatory Managers and address follow-up questions.
Global procedure ownership and site alignment
● Support Zoetis Global procedures by ensuring site alignment and execution.
● Track, complete, and document assigned operational assessments (including gap identification and follow-up actions) to maintain alignment with global requirements.
Regulatory intelligence and gap assessment
● Monitor and track relevant regulatory changes; assess applicability and drive site gap assessments.
● Coordinate and administer site gap assessments and follow-up action plans to sustain compliance.
Governance, quality systems, and continuous improvement
● Administer the Site Quality Council (e.g., scheduling, agenda development, metrics/material preparation, minutes, action tracking).
● Support Quality Systems improvement projects (process improvement, standardization, effectiveness/metrics, inspection readiness initiatives).
● Manage and maintain the site risk register, including facilitation of risk reviews, updates, and escalation.
Auditing and inspection readiness activities
● Maintain qualification as a Zoetis certified auditor (required).
● Perform select internal audits (and occasional supplier audits as needed) to maintain auditor competency and support inspection readiness.
● Conduct facility walkthroughs to assess inspection readiness, identify gaps, and drive actions to closure.

Education and Experience
Qualifications (Required)
· Bachelor's degree in a scientific, engineering, or related discipline (or equivalent experience).
· Demonstrated experience leading and coordinating regulatory inspections in a GMP-regulated environment.
· Required: familiarity with sterile vaccine, monoclonal antibody, and non-sterile pharmaceutical manufacturing facilities and the primary regulatory bodies supporting the site (EU, FDA, USDA) and applicable global markets.
· Strong knowledge of Quality Systems (e.g., deviation investigations, CAPA, change control, document control, training, risk management).
· Proven ability to lead cross-functional teams through influence (matrix leadership) and manage multiple priorities under tight timelines.
· Excellent written and verbal communication skills, including experience drafting formal regulatory responses and executive summaries.
· Zoetis certified auditor (or ability to achieve/maintain certification per Zoetis requirements).
Qualifications (Preferred)
· Experience interacting with multiple global health authorities and inspection types.
· Supplier auditing experience.
· Experience developing inspection readiness programs and governance routines.

Technical Skills and Competencies Required
● Regulatory inspection leadership and composure under pressure
● High professional maturity and executive presence in regulator-facing and site-facing interactions; maintains calm, respectful, and objective communication with colleagues and inspectors at all levels.
● Influencing without authority; stakeholder and escalation management
● Detail orientation with strong operational execution.
● Risk-based thinking and decision making.
● Clear, concise technical writing and presentation development
● Confidentiality and sound judgment in regulator-facing interactions.

Physical Position Requirements
● This is an on-site position based in Lincoln.
● Work is primarily performed in an office environment with sustained computer use and periods of sitting.
● Inspection readiness activities, inspections, audits, and walkthroughs require regular standing and walking in manufacturing, warehouse, and laboratory areas, including use of stairs and compliance with required PPE/gowning.
● Ability to lift/carry light materials (e.g., binders, laptop) up to ~25 lbs.
● Flexibility to work extended hours during inspections and critical deadlines, with occasional weekend support.
● Occasional travel (car/air) as needed.