Regulatory Inspection Manager

Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals.
At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow.
Benefits Include:
4 weeks accrued paid vacation and 13 paid holidays. 
401(k) match with company profit sharing.
Tuition reimbursement and Student Loan repayment program.
Great Health, personal, and family benefits starting day 1.
 
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.
 

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