Quality Assurance (QA) Manager - Bioanalysis

<h2≥Job Overview:</h2≥<p style="margin: 0px;"≥ </p≥<p style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;"≥Quality Assurance (QA) Manager - Bioanalysis</span≥</p≥<p style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;"≥Are you an experienced Immunochemistry (iChem) and/or LCMS scientist? Do you have previous management experience? If so, w</span≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;"≥e want you to join our Global QA team as the Quality Assurance (QA) Manager, Bioanalysis in Indianapolis, IN. </span≥</p≥<p style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: black;"≥Covance by Labcorp’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.</span≥</p≥<p style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;"≥Position Overview</span≥</p≥<ul≥<li style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;"≥Working knowledge of LC/MS bioanalysis, FDA Guidance for Industry: Bioanalytical Method Validation</span≥</li≥<li style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;"≥Manages QA group responsible for auditing Method Validation, GLP regulated and GCP regulated bioanalysis</span≥</li≥<li style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;"≥Interpret applicable quality regulations/standards and create appropriate policies and procedures</span≥</li≥<li style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;"≥Lead and manage interactions with clients and regulatory agencies</span≥</li≥<li style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;"≥Recruit, train, coach and develop individuals based on their development or business needs</span≥</li≥<li style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;"≥Consideration would be given to a scientist with commensurate experience</span≥</li≥</ul≥<p style="margin-bottom: 6.75pt;"≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif; color: #333333;"≥ </span≥</p≥<p style="margin-bottom: .0001pt;"≥<span style="font-size: 8.0pt; font-family: 'Arial',sans-serif; color: black;"≥#LI-DZ1</span≥</p≥<h2≥Education/Qualifications:</h2≥<ul≥<li≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)</span≥</li≥<li≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Experience may be substituted for education</span≥</li≥</ul≥<h2≥Experience:</h2≥<ul≥<li≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥8 years’ in regulatory environment (experience in GLP/GCP roles preferred) </span≥</li≥<li≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Experience & regulatory expertise of industry quality systems/standards</span≥</li≥<li≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Ability to interpret applicable regulations/standards</span≥</li≥<li≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Experience in leading process improvement initiatives</span≥</li≥<li≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Ability to communicate and negotiate internal stakeholders effectively</span≥</li≥<li≥<span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;"≥Ability to supervise resources in a single geographic location</span≥</li≥</ul≥