Quality Operational Readiness Leader

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Quality Operational Readiness Leader

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locations

Atlanta

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

JR00015090

What’s 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 Douglasville, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios. We are currently searching for a site Quality Operational Readiness leader to join our team. Position Summary: The site Quality Operational Readiness Leader:

1) will provide hands on guidance and direction to construct a new state-of-the-art pharmaceutical manufacturing site. Quality and regulatory expertise will be necessary to support design,

installation/validation,

manufacturing, testing and release of monoclonal antibodies and animal vaccines. 2) is accountable for implementing the Zoetis QMS to ensure the site is regulatory inspection ready. 3) ensures that the QA/QC function meets all regulatory compliance requirements and GMPs. 4) will partner with the site leadership team to hire the staff necessary to implement the Zoetis QMS at the plant. 5) has ownership of the Site Quality Risk Register during construction and up to site becoming fully operational. The risk register will be presented monthly to the project team and Zoetis leadership. Mitigation strategies for each identified risk will be driven to conclusion by the Quality Operations readiness leader. 6) uses data and metrics to drive continuous improvement in the site quality systems. Responsibilities: Establish and reinforce the Quality Culture on the Site. Ensure development, validation and implementation of Site operating systems (PAS-X, LES, BMS, SAP, LIMS, etc). Implement of Zoetis Quality Standards, and track and report gaps to the Zoetis QS. Develop and maintain Site Inspection Readiness. Develop and present any audit findings/remediation to site leadership. Ensure that products are manufactured in compliance with Registration File (and appropriate Reg Bodies). Ensure Product Release is done within Regulatory Standards and pertinent Registration Files. Ensure QC Testing meets Regulatory Compliance and GMPs. Demonstrate proactive ownership of the Site Risk Assessment process. Oversee the development and implementation of the Quality Plan. Develop metrics to deliver product and process improvement. Develop and maintain the Supplier Quality program and vendor certification. Ensure the Validation Master Plan is developed and maintained (.Validation strategy and site compliance). Technical Skills and Competencies

: Coach and mentor staff Create a Learning Organization Develop and champion the Quality Culture within the site Support the development of Quality goals and targets as part of the organization’s strategic plan. Ensure Training and Development plans are in place for all QA/QC associates. Develop Site Quality operations budget and resource planning for startup of the site Act as a change management and demonstrate strong leadership in a Change Management environment, Be a problem solver, utilizing root cause analysis methodology Utilize a process oriented mindset Demonstrate a data and continuous improvement orientation Be able to work well in complex environment Fluent in English, both written and oral.

Education and Experience

: BS in Science or Engineering is required; an advanced degree MS / PhD is preferred. 5-7 years of experience in a Quality Role in Animal Health / Human Health manufacturing is required, with demonstrated significant leadership experience. Operations or Quality Experience in Biological and/or Aseptic Manufacturing is desired. FDA, USDA, and EU regulated work experience is required. Fluent with Six Sigma and/or Lean Manufacturing. Physical Position Requirements The work environment characteristics described here are representative of those a colleague encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Candidate must have the ability to travel minimally. Occasional work on non-core work hours are anticipated. This position is site based in Lithia Springs GA (Atlanta). Incumbent must be able to access all areas of the facility. Use of necessary personal protective equipment is also required. Full timeRegularColleague 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. About Us

Join Zoetis

– and build your career with 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. Why Zoetis Zoetis has more than 70+ years of experience in delivering innovative, high-quality products and services that support the human-animal bond and help to ensure a safe and sustainable global food supply. Our Purpose At Zoetis, our purpose is to nurture our world and humankind by advancing care for animals while providing support for our colleagues, customers, and communities. Hear

from our colleagues from around the world as they share their purpose and what it means to work in animal health. Our Culture Our

Core Beliefs

are at the foundation of our culture, and we strive to create an environment where all colleagues feel valued and cared for and understand the important role we each play in embracing diversity, equity & inclusion

to improve the quality of our innovation, collaboration and relationships Opportunities at Zoetis We invest in the development of our colleagues and offer exciting opportunities to make a difference in a growing global industry. We are committed to creating an environment where all our colleagues can learn and grow in their career. Supported by managers and the organization, colleagues are empowered to take on challenges and experiences that help them reach their career goals and aspirations. At Zoetis, we are shaping the future of animal health. Results that Matter Our colleague listen, understand and make relevant contributions to our industry by working together with our customers and addressing the unique real-world challenges they face. We take pride in our cooperative and high performing spirits.

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