Manager, It Quality & Compliance

• Partner with business quality and ZTD functional areas so that high quality IT solutions are developed and deployed to meet customer needs, while adhering to applicable regulatory (GxP, SOX, Privacy/Data Protection etc.) and Zoetis internal policies & procedures
• Provide Compliance & Validation Services to colleagues regarding Regulatory (GxP), Data Privacy/Protection, Sarbanes-Oxley (SOX), Computer System Validation (CSV) & Data Integrity for projects and ongoing service delivery
• Participate in ZTD DTAP (PMO), TRM, and Compliance projects/initiatives representing Risk Management & Compliance
• Approve Deliverables based on Zoetis Solution Delivery Lifecycle (SDLC) and/or relevant risk-based process work (agile methodology) with business and ZTD to identify compliance gaps, conduct risk assessments and define and implement remediation plans
• Participate in routine reporting on the state of compliance within each functional areas of support
• Assure audit awareness & preparedness of operations and provide coaching / guidance as a compliance expert
• Support the analysis of data & implement data integrity principles for ZTD operations in order to identify and lead targeted continuous improvement efforts to improve data quality and operational process effectiveness
• Identify and work with internal TRM&C operations and ZTD organization to implement KPIs, metrics and standard reports used to identify service improvement opportunities
• Support GMP audits and inspections, Zoetis Internal audits and assessments, and maintain risk mitigation plans
• Responsible for managing and/or supporting development of ZTD’s process framework and qualification processes
• Enable operational controls alignment within ZTD functional areas focusing on segregation of duties, change management and harmonized release management processes
• Participate in conducting and designing functional specific assessments, based on standard TRM&C governance, to ensure adherence to processes and controls

• 5-8+ years of experience in Regulatory (GxP & CSV) Compliance
• Excellent customer relationship management skills
• Relevant certification such as CISA or CRISC are preferable
• 5+ years of experience in Information Technology
• Demonstrated skills for independently guiding quality and compliance activities during system development and implementation
• 5+ years of experience in the pharmaceutical or biotech industries supporting IT initiatives is a plus
• Demonstrated ability to communicate and negotiate with individuals and groups at multiple levels across the organization
• Expert in principles, theories, and concepts of regulatory compliance, and of pharmaceutical regulations; including industry knowledge of implementing controls within processes and tools.
• Bachelor’s degree in Computer Science, Business Administration, or related field; Master’s degree preferred
• Formal training and/or experience in FDA regulations & computer system validation space highly desired
• Be able to take a plan, direct the team and efficiently deliver it
• Ability to work independently, manage multiple priorities, and work in an unstructured environment

• Strategic thinking, leadership, and relationship management with a demonstrated ability to operate at senior levels of a large international corporation
• Proven ability to define and implement IT controls
• Senior level experience and understanding of relevant regulations, laws, and policies across multiple IT compliance domains (GxP, Privacy, InfoSec, etc) gained from career experience

Full timeRegularColleagueZoetis 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 [email protected] 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 “@zoetis.com”. 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.