Site Quality Lead

Site Quality Lead page is loaded## Site Quality Lead locations:
Durham time type:
Full time posted on:
Posted Yesterday job requisition :
JR
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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 site’s 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 it’s alignment with the Quality Policy and Quality Plan.

The position reports to the Platform Quality Leader.
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* 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 organization’s 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)
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* EDUCATION AND EXPERIENCE:

*** Bachelor’s 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…