Regulatory Inspection Manager

Zoetis is the worlds 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 Nebraskas 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 reimbursementand 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 sites 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)
Bachelors 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.

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party such as an Agency recruiter including unsolicited resumes sent to a Zoetis mailing address fax machine or email address directly to Zoetis employees or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Notice: Zoetis Recruiters will contact candidates via email from an address ending in @ and may also initially connect with candidates through LinkedIn including LinkedIn InMail. Zoetis does not use Gmail Outlook Yahoo or other web-based/generic email domains to communicate about job opportunities interviews or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @ please treat it as suspicious. For your security do not reply click links open attachments share personal or financial information or send money in response to unexpected or questionable recruitment communications.

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at to request an accommodation. Zoetis also complies with all applicable national state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at site or (2) via email to/from addresses using only the Zoetis domain of @. In addition Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be addition Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.