Validation Manager
Zoetis

Job Info

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What is it like to work for Zoetis, the world leader in animal health? Zoetis means something a little different to every colleague, but at our core, our purpose 'to nurture the world and humankind by advancing care for animals,' is what unites us in all our roles.

We're a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries. And we're excited to become a part of the Metro Atlanta, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios.

We are currently searching for a Validation Manager to join our team.

Summary

The Validation Manager will have responsibility to lead and oversee site validation activities within the site's initial mAbs Biopackaging Operations and future Biological and Pharmaceutical Operations, establishing and ensuring compliance with site validation procedures and industry regulations for validation activities. Validation activities include but are not limited to manufacturing and lab equipment, utilities and facilities qualification, computerized system validation and IT tools implementation, process transfer and validation, analytical method validation, cleaning validation and shipping validation.

The Validation Manager will have overall responsibility to assure that compliant, aligned, lean and efficient quality systems and tools are designed, deployed, implemented, monitored and maintained at the site to support the product lifecycle, from the initial phase of qualifying and commissioning the site through to commercial manufacturing and that compliance with cGMP is maintained through ongoing training and process review and on-going monitoring of Key Performance Indicators (KPIs) and quality metrics as applicable.

Reporting Structure

This position will reside in the Quality Organization, and together with partners and other stakeholders to ensure compliance and support execution of site validation activities.

Position Responsibilities

• Own, lead and monitor execution of site Validation Master Plans and be responsible for site quality system governance through management review to ensure its continuing suitability and effectiveness, notifying any predicted shortfall or discrepancies against timescale and budgets.
• Oversee and ensure Master Validation Sub plans for process, analytical, computer system, cleaning, equipment, and facility validation are maintained in alignment with Site Master Validation Plan.
• Interface extensively with the Global Manufacturing Technical Group, Quality Control, Quality Assurance, Production and Engineering departments to identify projects and problems requiring validation support.
• Support continuous validation and compliance to the Site Validation Master Plan including compliance with cGMP; Facilities, Equipment, Utilities, Laboratory Methods, Process, computerized Systems.
• Interact with all levels of management and staff to oversee and facilitate the validation process from inception to completion by enlisting cooperation, support, and approval for identified validation.
  • Author or approve project validation plans and final validation summary reports.
  • Own change control for major projects or work closely with project leads.
    • Identify and lead cross functional team based on project
      • Develop project plans to keep project on track
      • Ensure cohesiveness and involvement during project lifecycle between all areas
      • Track project progress and completeness.
    • Perform final approval on project completion
  • Work with validation SMEs to establish criteria/requirements for protocol details and ensure compliance with regulatory, corporate and site procedures. Monitor and support the execution of the protocols through training, facilitating and problem-solving activities.
• Oversee of site data integrity program
• Responsible for site process validation. Establish criteria/requirements as well as author protocols as needed.
• Provide support for Zoetis Information Technology (IT) and Automation Systems, including system implementation and protocol approval. For non-IT or Automation owned system, establish criteria/requirements as well as author protocols, as needed.
• Monitor validation activities to ensure they consistently remain in place, in use and in control, comply with Zoetis Global Quality Policies and Standards and meet the most current regulatory requirements and best industry practices.
• Monitor internal and external factors impacting validation system (i.e., emerging regulations, innovations that might enhance the pharmaceutical quality system), to ensure compliance with the changing regulatory environment.
• Support the development of quality goals and targets as part of the organization's strategic plan.

Education and Experience

• Undergraduate degree in pharmaceutical, biological, or chemical sciences
• Relevant advanced degree preferred
• 5-10 years relevant experience in Biological, Pharmaceutical and/or Animal Health industry, with at least 3 years relevant experience in Validation roles & managing validation activities

Technical Skills and Competencies Required

• Current knowledge of cGMPs and FDA, USDA, and EMA regulatory guidance required with emphasis on all elements of validation e.g., equipment, process, analytical and computer validation.
• Success in developing, implementing, and maintaining Quality Systems and Standards at manufacturing site level in accordance with regulations
• Demonstrated knowledge and success in validation of Quality Systems
• Ability to develop and adhere to self-directed standard work-organized and methodical with ability to take initiative with minimal guidance and be comfortable working both as an individual and as part of a team
• Exercises good judgment and drive change for competitive advantage
• Strong written and oral communication skills and ability to collaborate effectively with others
• Strong interpersonal, leadership and influencing skills, communication, and motivation
• Drive for superior results and passion to win with demonstrated record in getting things done
• Inspires continuous improvement and breakthrough thinking - flexible and adaptable to new and innovative ideas
• Ability to manage multiple projects simultaneously and prioritize work, goals, and tasks in accordance with division and corporate objectives
• Proficient in English
• Demonstrated written communication skills, as well as experience with presenting to leadership teams
• Assertive and sets clear direction
• Business awareness & continuity

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.

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 zoetiscolleagueservices@zoetis.com 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.

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