Director/Site Quality Lead
Zoetis

Chicago Heights, Illinois

This job has expired.


Position Summary

Reporting to the Quality Platform Leader (QPL), The Site Quality Lead (SQL) role for Chicago Heights & Eagle Grove Sites is accountable for product quality and both site's regulatory compliance standing - maintaining a state of Inspection Readiness for both sites and aligning with GMS Vision and Mission.

The Role oversees all activities of the Quality Units including Quality Assurance Operations, Quality Assurance Systems, Quality Control and Customer Analytical Support functions, and as defined in Zoetis Quality Standards. The role assures all regulatory compliance requirements and GMPs are followed. Regulatory Compliance includes, but not limited to FDA, USDA, Food Safety Modernization Act (FSMA), Customs/Border FDA inspections and all requirements of product registrations.

The Site Quality Leader is Responsible and leads the planning, implementation and control of site Quality Systems, and QA oversight of plant operations including qualification of manufacturing and laboratory equipment, QA IT tools, utilities and Facilities and ensure the site is ready to manufacture, test and release registration and commercial batches of Zoetis Active Pharmaceutical Ingredients (API's) Drug Substance and Type A Medicated Feed Additives (MFA) Finished goods. This role will also oversee all testing and compliance for Type B and Type C feeds.

The Site Quality Lead is a member of the Site(s) 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 role has ownership of the Site Risk Assessment Process - leading the Site Leadership through the process on a predetermined cadence and also co-chairs the site Quality Council (with the Site Lead) to drive continuous improvement and compliance objectives as well as prioritizing quality improvement initiatives. The Quality Lead uses data and metrics to drive continuous improvement in site quality systems as well as Product Quality. Additionally - the role is responsible for creating and executing the Site Quality Roadmap.

As a member of the Site Leadership Team the role of the Quality Leader is also responsible for fostering and leading a culture of partnership and inclusion with other Departments and excellence in delivery of key business drivers relating to Compliance, Supply, Strategy and Cost. This role will have budget oversight and will be responsible for interacting with multiple other business units in platform.

This position will achieve results through Leadership of Colleagues with a direct reporting relationship as well as indirectly through partnership as part of the site Leadership team and Global Quality Team- includes but is not limed to Quality Platform Lead, Platform Lead; Global Quality Functions - Systems, Auditing, External Supply, Customer Supply, manufacturing network, Manufacturing Site Leadership & Site Enabling Functions, Operational Excellence and VMRA and VMRD.

Position Responsibilities

  • Serving as a quality culture role model and instill a strong quality and compliance culture across the site(s)); Contributing member of the Site Leadership Team partnering with the site Lead and extended Site Leadership Team to ensure effective and appropriate integration of Quality with other key operating areas.
  • Implementation of Quality Standards - Providing Leadership and Direction for the development of Compliant, Robust and Lean Quality Management Systems on site, ensuring adequate Quality Oversight is in place and alignment with FDA 21 CFR 211, 226, 225, 504, FSMA FDA regulatory requirements and other US and export Regulatory requirements
  • Maintain Site Inspection Readiness. Promote Compliance Audit findings/remediation.
  • Partnering with other site and Global Functions to ensure on time, compliant supply and delivery of products to ensure commercial customer supply.
  • Ensure that products are manufactured in compliance with Registration File (and appropriate Reg Bodies)
  • Ensure Product Release is completed within Regulatory Standards and pertinent Registration Files.
  • Ensuring QC Testing meets Regulatory Compliance and GMPs.
  • Proactive Ownership of the Site Risk Assessment process.
  • Oversee the development and implementation of the Quality Plan / Quality Road Map
  • Share Leadership of Site Quality Councils and Metrics
  • Develop metrics and use effective governance systems for monitoring process performance and product quality, providing assurance of continued suitability and capability of processes,
  • Leadership and Direction for site-wide and departmental Continuous Improvement strategies and actions for improved Compliance, Quality Systems, process performance and product quality throughout the product lifecycle and in compliance with applicable regulations,
  • Maintain the Supplier Quality program and vendor certification.
  • Ensure the Validation Master Plan is compliant and up to date. (Validation strategy and site compliance)
  • Overall Site Product Portfolio Quality Stewardship owner and accountability.
  • Monitoring and communicating new and developing GMP compliance standards to the site - representing the site in corporate and industry Quality forums
  • Lead Representative for the site on all external GMP audits, including regulatory inspections.

Staff and Leadership Responsibilities
  • Leadership Development / Coaching of Staff; Ensuring required organization is in place and Creation of Learning Organization
  • Stewardship of the Quality Culture within the Quality Function as well as the Site.
  • Ensure Training and Development plans are in place for all Quality Colleagues
  • Create and Be accountable for the Site Quality operations budget and resource planning for roll up to the Site Quality Budget, including capital planning within Quality but input Quality requirements to site Capital Plans.
  • Support the development of Quality goals and targets as part of the organization's strategic plan.
  • Recruiting, training, and appraising the performance of a Quality management level staff group. Ensuring appropriate training and development programs are in place across the department. Additionally, ensuring that the performance appraisal system is applied correctly and fairly, and that high caliber staff are identified and developed to meet their potential. Preparing and regularly updating a succession plan for the department.
  • Ensure that all employees in Quality are properly trained, competent for the task, and have adequate protective clothing/equipment to prevent, as far as reasonably practicable, the risk of accidents and detriments to health.
  • Responsible for Leading Safety Compliance within Quality and the Laboratory Function including ensuring as far as reasonably practicable, that workplaces, machinery, equipment, processes under their control are safe.
  • Ensure that Risk Assessments are completed for all tasks from which an injury could arise, and that actions are implemented to reduce these risks where reasonably practicable.
  • Ensure that all dangerous occurrences, accidents, safety, and environmental incidents within Quality are investigated, and that preventative actions are assigned and implemented.
  • Supervision of 4 direct staff reports and Total Site Quality Organization of 28 head count, including temporary contract workers (contingent employees)

Education and Experience
  • Science or Engineering BS / MS / PhD
  • Demonstrated significant leadership experience in a Quality Role in Animal Health / Human Health manufacturing
  • Operations or Quality Experience in Feed Manufacturing desired - min 10 years
  • Comprehensive knowledge of world-wide GMP regulations and expectations governing facilities, equipment and procedures for the manufacture and control of API and MFA (min including FDA, USDA, Food Safety Modernization Act (FSMA), and Customs).
  • Fluent with Six Sigma and/or Lean Manufacturing recognized qualification desired (Yellow Belt, Green Belt or Black Belt) with demonstrated delivery of improvements

Technical Skills Requirements
  • Does well in a Change Management environment, Acts as a Change Agent Flexible, adaptable and receptive to new and innovative ideas.
  • Process oriented mindset; data and continuous improvement orientation
  • Problem solver, familiar with root cause analysis methodology
  • Able to work well in complex environment with Strong people skills, leadership, communication and motivation.
  • Ability to work constructively within a team-based organization.
  • Able to operate and contribute as part of a cross functional leadership team at a site and strategic level which supports the business.
  • Proven Ability to Manage and Develop people and align others around common objectives
  • Demonstrates strong leadership consistent with Zoetis Core Values.
  • Has a continuous improvement mindset, sets high standards and creates a culture of commitment to GMP compliance and product quality & Inspires Continuous Improvement and Breakthrough Thinking.
  • Exercises Good Judgment and Drives Change for Competitive Advantage.
  • Strong written and oral communication skills.
  • Drives for Superior Results and Passion to Win.

Physical Position Requirements
  • Ability to access all areas of the facility
  • Some travel to other Zoetis facilities may be required (< 5%). (This is Chicago Heights, Illinois Site based position with travel to the Eagle Grove Iowa site required.)
  • Occasional non-core hour work anticipated

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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