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(Archived) Quality Assurance Leader

Last Updated: 1/22/21

Job Description

Position Summary

Direct the Quality Assurance functions for the White Hall site to ensure that only products meeting high quality standards, customer expectations, and regulatory requirements are provided to our customers.

Position Responsibilities

  • Oversee and manage the Quality Assurance Colleagues. Plan, initiate, and direct policies, processes, and procedures to ensure all products manufactured by White Hall meet applicable USDA and Zoetis quality standards, as well as the regulatory requirements of all destination countries.
  • Manage quality assurance staff providing submission of samples for products to be tested by the Control Laboratories. Ensure processes and procedures are in place for sample submission to USDA and archival of samples to support products.
  • Manage the Quality Assurance Team to ensure the processes, systems, and facilities utilized at the White Hall site are continuously operated in compliance with government regulations and Zoetis guidelines by coordinating and participating in periodic audits or inspections of the site.
  • Work with Regulatory Compliance to ensure all product quality actions such as quarantine hold, stop sales, withdrawal actions, or recalls of biological products manufactured by or distributed by White Hall are performed according to regulatory requirements and Zoetis Quality Standards.
  • Manage Quality Assurance in an effective manner within budget guidelines, where possible.
  • Ensure consistent manufacturing and control systems are in place by overseeing the review and approval of critical Standard Operating Procedures and all biological manufacturing Batch Records.
  • Monitor and identify when improvements are needed with the Quality Assurance activities.
  • Work with Lincoln QO and site management to ensure proficient and knowledgeable GMP auditing and inspection staff by providing periodic training on pertinent subjects and, where applicable, provide the opportunity to achieve formal certification recognized by international authorities.
  • Ensure continued regulatory compliance within Establishment 190 sites by actively participating on key teams and task forces and making appropriate recommendations when needed to assure compliance.
  • Advise Management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements.
  • When adverse trends of field complaints concerning the quality of Zoetis products are identified, work with the manager of field complaints and manufacturing to take appropriate corrective action.
  • Lead GMP regulatory inspections of White Hall Operations and actively participate in other regulatory inspections, when required.
  • Actively participate in industry and trade association committees to align Zoetis Quality Standards, government regulations, and the quality needs of Animal Health customers.

Education and Experience

  • Bachelor’s Degree with 7 years or equivalent expereince.
  • A minimum of three years QA/QC Leader experience including budget and supervisory responsibilities.
  • A thorough familiarity with US. Regulations (USDA) for biological products and their application.
  • Excellent written and verbal communication skills.

Technical Skills and Competencies

Minimum Qualifications:

  • Demonstrated ability to perform and reach targeted conclusions.
  • Strong written and oral communication and ability to effectively direct a team of professionals.
  • Ability to establish appropriate timelines to meet project milestones and hold colleagues accountable to timelines and activities.
  • Process and detail oriented with the ability to review and/or prepare detailed structured documents.
  • Ability to develop solutions to routine and complex problems.
  • Demonstrated organizational, administrative skills, in addition to proven skills in multi-tasking and prioritizing projects in support of standard work.
  • Ability to communicate effectively with Team Members to facilitate completion of required Quality Assurance activities to meet all deadlines.

Preferred Qualifications:

  • Demonstrated knowledge of the Deviation (QTS), Change Control (QTS), Laboratory Information Management (LIMS) and Manufacturing systems.
  • Experience in validation of processes, analytical methods, equipment, cleaning, software, computer systems, etc.
  • Experience in Quality Oversight of product transfer activities in a GMP environment.
  • Demonstrated ability leading a complex team and influencing colleagues with no direct report relationship
  • Hands on experience with change management processes, manufacturing operations, quality operations, and/or regulatory affairs.

Physical Position Requirements

  • This position requires sitting, standing, and walking with occasional overtime/weekend work.
  • Must wear appropriate gowning and PPE (Personal Protective Equipment) in manufacturing/production areas.

Full time

Regular

Colleague

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 [Register to View] 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 [Register to View] 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.

Company Details

Parsippany, New Jersey, United States
Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.