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(Archived) ESQA Contract Quality Leader

Last Updated: 10/18/21

Job Description

JOB DESCRIPTION:

The mission of the External Supply Quality Assurance (ESQA) team is to ensure the quality of Zoetis’ animal health products through management of outsourced activities and oversight of third party contract manufacturers, thereby ensuring the reliable supply of quality products to our patients and their caregivers.

Each ESQA Contract Quality Leader (CQL) has the responsibility for the oversight of multiple US/CLAR based contract manufacturing organizations, ensuring global GMP Quality and Regulatory Compliance standards are maintained and the expectations of Zoetis as Marketing Authorization Holder or Distributor are met.

This is a relatively independent position operating with minimal supervision requiring a range of GMP experience and technical knowledge, interacting with high levels of management at contract manufacturers. The ESQA CQL will also be expected to interact with other Zoetis business, supply and manufacturing units and may be involved in cross-functional teams. Each ESQA CQL is expected to be customer and business focused and willing to travel up to 20%. This job can be located anywhere within the US/LAR region.

JOB RESPONSIBILITIES:

Contractor Management: Own and manage the contractor relationship for Quality and Regulatory compliance to ensure contractors have applicable quality systems, comply with GMP/regulatory requirements and Zoetis expectations for marketed products. Routine oversight includes responsibility for Quality Agreements, Change Control, Deviation Management, Market Actions, Lot Approval, Complaint Handling, Annual Product Review, Stability Studies, Validation Approval and Global Compliance Audit Support.

New Product Introduction: Support Zoetis business development opportunities in selection, due diligence audit and evaluation of potential contractors in the process of New Product Introduction by supplying appropriate quality input.

Product Transfers: Act as Quality subject matter expert for product transfer teams, advising on Zoetis’ and GMP expectation regarding process validation and analytical method transfers performed at the contractor.

Regulatory Compliance: Support and/or conduct Regulatory compliance assessments at contractors. Facilitate the process of documentation retrieval and collation to support Marketing Authorization renewals and variations. Act as QA focal point for regulatory communications and changes.

ESQA Quality Systems: Contribute to the maintenance and development of the ESQA and Zoetis Quality Governance models.

EDUCATION AND EXPERIENCE

  • Bachelor/Master degree in Engineering, Pharmaceutical Science, Microbiology, Chemistry or equivalent.
  • Experience in Pharmaceutical industry supporting manufacturing operations,
  • Fluent in English (written and spoken) and ideally knowledge of Portuguese or Spanish is a distinct advantage

TECHNICAL SKILLS REQUIREMENTS

  • Demonstrate knowledge of a range of products and regulatory requirements in the diverse portfolio of medicinal products (ideally including Animal Health).
  • Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor. Prepared to take initiatives with an ability to handle and prioritize issues accordingly as they arise
  • Ability to prioritize workload to act and work independently, a confident decision maker with the ability to recognize significant issues requiring immediate escalation.
  • Diplomatic in communication with internal and external stakeholders, strong negotiating skills and a demonstrated ability to resolve conflict to the benefit of all parties.

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.