Job Description:
Location: Lincoln, NE
Role Description
The Lincoln Site Quality Lead role is accountable for product quality and the site's regulatory compliance standing, ensuring adherence to all regulatory compliance requirements and cGMPs, maintaining a state of Inspection Readiness and ensuring a continuous supply of high-quality product from the site. This role also has Quality Oversight and support for the White Hall, Illinois Zoetis manufacturing facility.
The Site Quality Lead champions the quality culture and takes proactive steps to ensure a high level of quality and compliance at the site.
The position reports to the Platform Quality Leader.
The Site Quality Lead is a member of the Site Leadership Team and participates in setting the strategic direction of the quality unit and the site as well as managing day to day quality operations. The position also co-chairs the site Quality Council (with the Site Lead) to drive continuous improvement and compliance objectives as well as prioritizing quality culture improvement initiatives.
The role has ownership of the Site Risk Assessment Process - leading the Site Leadership through the process on a predetermined cadence.
The Quality Lead uses data and metrics to drive continuous improvement in site quality management systems as well as Product Quality. Additionally - the role is responsible for creating and executing the Site Quality Roadmap.
Stewardship and Leadership of the Quality Culture within the Quality Function as well as across the Site.
- Establishing and Reinforcing the Quality Culture on the Site; Contributing member of the Site Leadership Team
- Implementation of Quality Standards and ensures sustainability of the Quality Management Systems
- Maintains Site Inspection Readiness for all applicable regulatory agencies including USDA, FDA, VMD, and European Agencies and acts as the company point of contact to lead inspection readiness for the site.
- Ensure that products are manufactured and released in compliance with pertinent Regulatory standards and Registration Files (and requirements of appropriate Regulatory Bodies) and partnering with the regulatory team on all activities relating to regulatory compliance.
- Overall Site Product Quality Stewardship owner and accountability.
Stewardship and Ownership of Site Quality Management System
- Promote Compliance, remediate Audit findings, and ensure quality standards are maintained throughout the site.
- Ensuring QC Testing meets Regulatory Compliance and GMPs via overseeing development and implementation of standards, methods, and procedures for inspecting, testing, and analyzing both raw materials and finished products.
- Proactive Ownership of the Site Risk Assessment process including oversight of the supplier quality programs, including supplier audits and supplier qualification processes.
- Oversee the development and implementation of the Quality Plan / Quality Road Map
- Co-Leadership of Site Quality Council and Metrics
- Develop metrics to deliver product and process improvement.
- Ensure the Validation Master Plan is compliant and up to date. (Validation strategy and site compliance)
- Collect and analyze process data for new or modified products/processes.
- Investigates Quality related Customer Complaints
- Collaborate with other organization/sites leaderships concerning quality management system activities.
Staff and Leadership Responsibilities
- Champion Leadership Development / Coaching of Staff; Creation of Learning Organization
- Ensure Training and Development plans are in place for all Quality associates.
- Development of Site Quality budget and resource planning for roll up to the Site and Company budget.
- Support the development of Quality goals and targets as part of the organization's strategic plan.
Organization Relationships
This position will achieve results through Leadership of Colleagues with a direct reporting relationship as well as indirectly through partnership and collaboration with the site Lead and extended site Leadership team and company functions as listed below* to assure quality goals and strategic objectives are met.
*Quality Platform Lead, Global Quality Organization including Quality Systems and Standards (QSS) and Global Quality Compliance Auditing. Bio/BioPharma Platform Leadership Team, GMS Leadership Team, Site Enabling Functions (i.e.: Engineering; GMT; Finance, HR etc.), Operational Excellence, Regulatory Affairs, Veterinary Medicine Research and Development.
Education and Experience
- Biological, Chemistry or Engineering BS / MS / PhD
- Demonstrated significant leadership experience in a Quality Role in Pharmaceutical / Vaccine / Animal Health / Human Health manufacturing.
- Operations or Quality Manufacturing preferred
- FDA, USDA, and European Agencies regulated work experiences required.
- Fluent with Six Sigma and/or Lean Manufacturing
Technical Skills Requirements
- Excellent communicator and collaborator
- Does well in a Change Management environment, Acts as a Change Agent
- Problem solver, root cause analysis methodology
- Process oriented mindset; data and continuous improvement orientation
- Able to work well in complex environment.
Physical Position Requirements
- Position located in Lincoln, Nebraska
- Some off-site travel
- Occasional non-core hour work anticipated.
Acronym Definitions
- GMT: Global Manufacturing Technology
- QSS: Quality Systems and Standards
- USDA: United States Department of Agriculture
- VMD: Veterinary Medicines Directorate (UK Regulatory Agency)
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.
More jobs in Lincoln, Nebraska
|
UPS |
|
The University of Nebraska-Lincoln |