Product Development Quality Leader

Company: Zoetis, Inc
Location: Lincoln
Posted on: October 23, 2024

Job Description:

Role DescriptionZoetis's Veterinary Medicine Research and Development (VMRD) Product Quality group is seeking highly skilled, detail-oriented, and forward-thinkingQuality Leaders who will be active members of vaccine, biopharma and pharma co-development teams providing input on co-development strategy (clinical/PK supplies, design of experiments, analytical method development and transfer, registration batch manufacture, submission planning, etc.) throughout the lifecycle of a project including transfer to Zoetis Global Manufacturing & Supply (GMS).Their goal will be to assure that long-term product sustainability is a process design deliverable by guiding co-development teams with a quality mindset. Knowledge from product and process development is the basis for establishing an approach to control of the manufacturing process that results in products with the desired quality attributes. The Quality Leaders will help to ensure that during process/product development, variation, impact of variation and control of variation is understood and well documented. The successful candidate will make sure that the appropriate level of quality and compliance is applied across all aspects of the process design stage of process validation, collaborating with both VMRD and GMS. Quality Leaders will be involved in key decision making and supportive processes of the co-development team such as risk assessments, determination of Critical Process Parameters, Critical Quality Attributes (specifications) and control strategies. The close partnership with GMS will continue across the qualification and verification phases of validation to ensure seamless transition of product quality to commercial manufacturing.The Quality Leaders will foster a culture of excellence and harmonize practices across diverse projects. They will be responsible for the review and approval of GMP documentation (batch records, protocols, reports, stability, etc.) for each project and for the maintenance and continuous improvement of the VMRD Quality Management System policies in accordance with regulatory requirements, Zoetis standards and industry best practices.Each Quality Leader will be responsible for supporting multiple projects and interfacing with partner groups in the co-development teams across the organization in both VMRD and GMS. These include global development teams, regulatory, GMS quality, formulation, chemistry, analytical, bioprocess development, PK/PD, clinical, CROs, etc.An Ideal Candidate Would:

• As part of the core co-development team, represent VMRD Product Quality through product development. Provide strategic input and participate in highly matrixed cross-functional teams with operational leaders to prioritize processes and roadmaps and drive innovation. Collaborate to develop and implement innovative solutions to improve business processes, reduce compliance risk, while driving efficiency.
  • Interpret and stay updated on relevant regulation and guidelines from health authorities.
    • Ensure that all processes, documentation, facilities, and products comply with requirements. Assure adherence to appropriate GMP practices with a forward-looking perspective to anticipate and address emerging challenges across the business lines.
    • Ensure a proactive and adaptive approach to evolving project needs. Champion the implementation of efficient and compliant processes. Foster a culture of quality and continuous improvement.
    • Use a quality-embedded mindset and practical knowledge of industry, customer requirements, and general business environment to define appropriate actions.
      • Operate within quality management systems to lead, own, and drive investigations, corrective/preventive actions, and change control activities in the design phase
        • Partner with Quality Operations in GMS during the qualification and verification phases of product lifecycle to ensure a seamless approach to process transfer and to knowledge management.
        • Identify opportunities for automation and integrating technological solutions to simplify compliance tasks and improve quality.
          • Demonstrate resilience in the face of challenges, maintaining composure and guiding the team through periods of change.Minimum Qualifications / Essential Skills and Competencies
            • Bachelor's degree and relevant experience across technical (chemistry, analytical, formulation, bioprocess development, etc.) disciplines with a demonstrated track-record of constructive influence on product development teams. Minimum 10 years pharmaceutical industry experience.
            • Strong leadership skills.
            • Ability to work independently at a high level.
            • Strong interpersonal skills and accountability in day-to-day interactions. Nice-to-Have
              • Masters/Graduate Degree
              • Quality Operations experienceFull timeRegularColleagueAny 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.

Keywords: Zoetis, Inc, Lincoln , Product Development Quality Leader, Other , Lincoln, Nebraska