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Senior Manager QA Process Lead (Individual Contributor)

Laboratory Corporation of America Holdings (Covance)

Raleigh, North Carolina, United States

<h2≥Job Overview:</h2≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="font-size: 11.0pt;"≥The Senior Manager QA Process Lead position is an individual contributor that has responsibility for oversight and delivery of the Internal Process Compliance function activities.  This position and department will be aligned as partners to the functional areas of the Clinical Development and Commercialization Services (CDCS) business to ensure appropriate quality/compliance oversight and solution partnering. Driving compliance excellence within the organization through execution of key activities, improvement methodologies and governance forums. Of importance are the requirements to lead, strategize, partner and influence across various functions and locations. </span≥</p≥<p style="margin: 3.0pt 0in 3.0pt 0in;"≥<span style="font-size: 11.0pt;"≥Provides regulatory compliance and quality assurance advice, guidance and support to internal CDCS teams and functions and collaborating with other internal stakeholders (e.g; Legal) for proactive interactions and quality management.</span≥</p≥<p style="margin: 3.0pt 0in 3.0pt 0in;"≥<span style="font-size: 11.0pt;"≥This position can be remote-based.</span≥</p≥<h2≥Education/Qualifications:</h2≥<ul≥<li style="margin-left: .25in;"≥<span style="font-size: 11.0pt;"≥A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 11.0pt;"≥Experience may be substituted for education.</span≥</li≥</ul≥<h2≥Experience:</h2≥<ul≥<li style="margin-left: .25in;"≥<span style="font-size: 11.0pt;"≥10 years in regulatory environment (experience in GXP roles) </span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 11.0pt;"≥Experience & regulatory expertise of industry quality systems/standards</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 11.0pt;"≥Ability to interpret applicable regulations/standards</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 11.0pt;"≥Ability to analyse and interpret data in order to lead process improvement initiatives</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 11.0pt;"≥Ability to communicate and negotiate with internal stakeholders effectively</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 11.0pt;"≥Ability to distill critical information</span≥</li≥<li style="margin-left: .25in;"≥<span style="font-size: 11.0pt;"≥Ability to effectively lead project teams to implement change</span≥</li≥</ul≥

Job posted: 2021-01-26

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