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Site Quality Lead
Site Quality LeadZoetis • Durham, North Carolina, USA
Site Quality Lead

Site Quality Lead

Zoetis • Durham, North Carolina, USA
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  • [job_card.full_time]
  • [job_card.temporary]
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POSITION SUMMARY :

The Site Quality Lead role is responsible for the leadership and oversight of all Quality functions at the site including Quality Assurance Quality Control Quality Operations and Compliance. This role ensures that product quality and the sites regulatory compliance are maintained at the highest standards fostering a state of inspectional readiness.

As a champion of the Quality Culture the site Quality Lead proactively safeguards and strengthens the integrity of quality and compliance across the site. This role ensures the site Quality Policy is understood implemented and sustained at every level of the organization and maintains the independence and authority of the Quality unit. The Site Quality Lead is accountable for developing coaching and empowering staff ensuring systems and processes meet or exceed Zoetis and regulatory requirements and that the Quality unit is support by adequately trained resources.

A key member of the Site Leadership Team the Site Quality Lead contributes to defining the strategic direction for both the quality unit and the broader site while managing day-to-day quality operations. Responsibilities include establishing and maintaining the annual Site Quality Plan Standard Operating Procedures and a robust Quality Audit program.

The Site Quality Lead co-chairs the Site Quality Council driving continuous improvement and compliance objectives and prioritizing quality initiatives. This role leverages data and metrics to enhance site quality systems and product quality and is responsible for developing and executing the Site Quality Roadmap. The Site Quality Lead ensures that executive management is informed and engaged in Management Reviews to evaluate the effectiveness of the quality system and its alignment with the Quality Policy and Quality Plan.

The position reports to the Platform Quality Leader.

POSITION RESPONSIBILITIES :

  • Establishing / Reinforcing the Quality Culture on the Site.
  • Maintain Site Inspection Readiness.
  • Promote Compliance Audit findings / remediation.
  • Ensure that products are manufactured in compliance with current processes.
  • Ensure Product Release is done within current quality standards.
  • Ensuring QC Testing meets within current quality standards.
  • 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 to deliver product and process improvement.
  • Maintain the Supplier Quality program and vendor certification.
  • Create and be accountable for the Site QA / QC Budget.
  • Champion Leadership Development for the Site Quality Staff.
  • Overall Site Product Portfolio Quality Stewardship owner and accountability.
  • Facilitate agency inspection and notified body audits.

STAFF AND LEADERSHIP RESPONSIBILITIES :

  • Leadership Development / Coaching of Staff; Creation of Learning Organization
  • Stewardship of the Quality Culture within the QA Function as well as the Site.
  • Ensure Training and Development plans are in place for all QA associates.
  • Development of Site QA operations budget and resource planning for roll up to the Site Quality Budget.
  • Strong Communication skills written and verbal.
  • Support the development of Quality goals and targets as part of the organizations strategic plan.
  • ORGANIZATIONAL RELATIONSHIPS :

  • Quality Platform Lead
  • Global QSS
  • Manufacturing Site Leadership
  • Corporate Quality Auditing
  • Site Enabling Functions (ie : Engineering; GMT; Finance etc)
  • Operational Excellence
  • VMRA and VMRD
  • RESOURCES MANAGED :

    Financial Accountability

  • Manage department budget in addition to personnel costs. Responsible for ensuring plant stays in compliance with all applicable entities so as to ensure continuous supply of products.
  • Supervision

  • Direct / Indirect : 3 / 2 staff reports
  • Quality Unit also utilizes approximately 1-2 temporary contract workers (contingent employees)
  • EDUCATION AND EXPERIENCE :

  • Bachelors degree in Science or Engineering required; advance degree preferred.
  • Proven leadership experience in a Quality function within Animal Health or Human Health Medical Device industries
  • 7-10 years of progressive Quality experience in biological device and / or automation manufacturing environments.
  • Extensive background in GMP and ISO 9001 regulated operations.
  • Proficiency in lean manufacturing methodologies
  • Exceptional communication problem-solving and team development skills
  • TECHNICAL SKILLS REQUIREMENTS :

  • Leads in 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.
  • Experience in SAP / PLM systems
  • Facilitate inspections
  • PHYSICAL POSITION REQUIREMENTS :

  • Position located in Durham NC
  • Minimal off-site travel
  • 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 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 site or (2) via email to / from addresses using only the Zoetis domain of @. 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 addition Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

    Key Skills

    Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

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