Regional Compliance Auditor (RCA)
Zoetis

Trenton, New Jersey

Posted in Pharmaceuticals


This job has expired.

Job Info


POSITION LOCATION: ANYWHERE IN THE UNITED STATES WITH PREFERENCE NEAR A ZOETIS US SITE LOCATION

POSITION SUMMARY

  • The Regional compliance auditor (RCA) will Plan audit program for the region
  • The Regional Compliance Auditor will conduct on-site audits of Zoetis manufacturing sites and its suppliers - with the goal of determining compliance gaps and necessary remediation plans. The auditor will promptly deliver/communicate audit findings using predetermined processes and methodology.
  • The RCA will (as needed) assist with mock regulatory inspections as well as supporting agency inspections. Additionally - the auditor will gather, track, trend, and disseminate regulatory compliance findings - from internal as well as external inspection sources.
  • Stewardship of the auditing processes for Zoetis
  • The RCA will work closely with QSS and Surveillance colleagues to stay abreast of current compliance regulations and points of key inspection trends.

POSITION RESPONSIBILITIES
  • Plan audit program for the region with sites and center functions for internal sites, suppliers, and contractors. Through the coordination of the Risk assessment process
  • Oversee the global audit program for the region
  • Manage audit firms in local markets in the region used to execute Animal Health audits of contractors and suppliers.
  • Ensure that the site auditors in the region are developed and trained.
  • Interface with Quality Platform Leaders on GQCA audit activities and issues identified during GQCA audits.
  • Review and approve audit reports.
  • Consolidate outcome of BOH audits, GQCA audits, EHS audits, regulatory letters, manufacturing alerts and other relevant documents for a specific site, contractor or supplier to identify trend and ensure CAPA plan is implemented
  • Conducting quality audits of global and regional Zoetis Global Manufacturing and Supply Sites (GMS), Suppliers and Contractors
  • Conduct Mock PAI and inspection readiness assessments at GMS Sites and contractors
  • Support due diligence assessments
  • Support regulatory agency inspections and conduct risk assessment of regulatory agency observations
  • Follow up and tracking of CAPA completion
  • Train sites and center colleagues on conducting audits (auditor qualification)
  • Provide technical expertise as requested and conduct business interactions in ways that reinforce and compliment Zoetis quality assurance programs.
  • Support due diligence audits and programs as needed
  • Stewardship of the auditing processes for Zoetis by ensuring that the global audit processes are fit for purpose and aligned to business needs
  • Act as an auditing SME and coach and support on site auditors as needed and assigned
  • Act as a coach and trainer for regional and site auditors
  • Zoetis Quality Culture ambassador

EDUCATION AND EXPERIENCE
  • Science or Engineering Bachelors / Masters Degree (Microbiology or Immunology Preferred)
  • Significant Operations and/or Quality experience (5+ years) in Animal Health/Human Health manufacturing
  • Experience as an FDA/USDA or similar Regulatory Agency Inspector
  • Sterile Manufacturing/Biologics/Vaccine experience
  • Medical device and or diagnostics experience is a distinct advantage
  • Demonstrated ability to operate successfully in a matrix organization
  • Six Sigma Black Belt / Green Belt or Lean Practioner Preferred
  • Experience in working with FDA, EU, USDA, Chinese regulations.

TECHNICAL SKILLS REQUIREMENTS
  • Demonstrated knowledge in a Quality Operations Role
  • Fluent with compliance regulators
  • Excellent communication skills (written, oral, and listening)
  • Demonstrated independent contributor
  • Deep expertise in planning, organizing, and follow up methodology; punctual
  • Ability to develop and adhere to self-directed standard work.
  • Ability to analyze data and synthesize to enable tracking and trending of large issues
  • Process Owner Management
  • Continuous Improvement; Systems and Process mindset
  • Project management experience

PHYSICAL POSITION REQUIREMENTS
  • Location: Unspecified / Regional
  • Position requires flexible work hours, to accommodate varying sites, locations, and markets' time zones
  • This position will require fluent use of teleconferencing and WebEx tools, as well as SharePoint technologies, to share and manage information with global locations and manufacturing sites
  • Travel: Estimated 50% global travel

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 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.


This job has expired.

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