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(Archived) Quality Inspection/Audit Manager

Last Updated: 8/05/21

Job Description

Position Summary

The Quality Audit Manager is responsible for maintaining the Lincoln Operations Quality Audit (internal and external) and Regulatory Inspection systems in alignment with current global regulations and Zoetis policies/procedures. Responsibilities will include management of a team of Inspection/Audit Specialists supporting these systems. Inspection, GMP internal audit and external audit systems.

Position Responsibilities

  • Manage internal and external Quality audit programs to ensure alignment with all applicable regulations and Zoetis Policies and Procedures
    • Build internal audit schedule and external audit schedule using risked based approach. Assign audit type based on risk level.
    • Assign audits to certified auditors
    • Review and approve completed audit reports
  • Oversee site internal and external auditors
    • Assess performance
    • Set objectives
    • Manage workload
  • Manage Regulatory Inspections
    • Work with regulatory bodies to plan & schedule Inspections
    • Partner with QO Leadership team to assign inspection team
    • Assign inspection responsibility to Inspection/Audit Specialist
      • Preplanning: pre pull documents, area walk throughs, SME preparation and organization of inspection logistics
      • Post Inspection: CAPA compilation and tracking
    • Monitor Inspection adjust responsibilities and staffing to ensure successful inspection
    • Work with site to develop proper CAPA to resolve inspection findings
  • Plan and conduct quality assurance audits of more complex and higher risk Zoetis suppliers and contract service providers: Contract Laboratories, Active Pharmaceutical suppliers, sterilizers, animal-derived raw material suppliers for vaccines, sterile material suppliers, chemical suppliers, critical suppliers, primary and secondary packaging suppliers, warehousing, and distribution sites
  • Identifying opportunities to help assure high quality standards for products and compliance with prevailing regulatory laws and requirements and current Zoetis policies
  • Utilize expertise of quality systems, data integrity, software compliance and GMP requirements to conduct audits and provide Gap analyses and risk assessments
  • Keep current with company policies, industry guidelines/standards, and government regulations
  • Manage Schedule adherence
  • Monitor system performance through applicable Key Performance Indicators (KPI) and report performance to leadership
  • Promote continual improvement in the auditing and inspection systems
  • Provide guidance on issues such as deviations and non-conformances resulting from an audit or regulatory inspection
  • Stay current on regulations : USDA, FDA, EU, Russia, Turkey, PICs as well as other emerging market regulations. Work with Lincoln Operations and Zoetis leadership to establish strategies for compliance
  • Travel up to 30% of the time

Education and Experience

Required

  • Undergraduate degree in engineering, science, or other degree with applicable experience
  • Ten years related experience. The related experience should be in one or more of the following disciplines: Quality Assurance or Sterile and Non-Sterile Manufacturing
  • 2-4 years of relevant experience in auditing, Animal Health/ Pharma industry. Preference given to those with biological experience.
  • Familiarity with USDA, FDA, EU, and foreign regulatory laws

Preferred

  • > 4 years of relevant experience in auditing, Animal Health/ Pharma industry. Preference given to those with biological experience. Including experience conducting site audits and assessments, both internal and external (e.g. suppliers, contract service)
  • Relevant advanced degree or training/certificate in auditing preferred

Technical Skills and Competencies Required:

  • Quality orientation and high attention to detail
  • Strong working knowledge of cGMPs (Pharmaceuticals & Vaccines)
  • Exceptional communicator with strong persuasion skills and presentations
  • High level of understanding of the criteria for selection for supplier management and GMP auditing services in the Biological and Pharmaceutical Industry
  • Excellent analytical skills and the ability to access and resolve difficult compliance situations
  • Demonstrated ability to troubleshoot and reach targeted conclusions
  • Excellent interpersonal effectiveness and communication skills (written and oral) required to interface with Zoetis suppliers and across departments, sites and management levels
  • Proven ability to operate in an independent manner and manage multiple projects at one time
  • Proven ability to lead high visibility and multi-disciplinary investigations and projects
  • Proficiency in English

Physical Requirements

Up to 30% Travel Possible

Full time

Regular

Colleague

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 [Register to View] 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 www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of [Register to View] 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 disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Company Details

Parsippany, New Jersey, United States
Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.