Quality Experts
MIDRegulatory AffairsPhD
Market Rate — Natural Sciences Managers
25th
$120K
Median
$158K
75th
$205K
BLS 2024 data (national)
Description
<p style="text-align:left"><b>Job Description Summary</b></p>#LI-Onsite <br>Location: Târgu Mureş, Romania<br>This role is based in Târgu Mureş, Romania. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.<br>Join Novartis and help ensure analytical excellence, regulatory compliance, and continuous improvement across our quality operations. We are currently mapping the market for experienced Quality Experts.<p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Job Description</b></p><p><b>Key Responsibilities</b></p><p></p><ul><li>Independently plan and perform analytical studies, including method development, verification, validation, and transfer. </li><li>Implement and optimize new analytical techniques and support stability studies and other analytical support activities. </li><li>Interpret, document, and report analytical results to provide timely, high-quality support to quality control, production, and development. </li><li>Own and manage all analytical documentation (analytical plans, sampling plans, specifications). </li><li>Ensure equipment qualification and effective management of reference standards. </li><li>Drive technological improvements and process optimization, including the upgrade and transfer of expertise within quality control. </li><li>Execute complex quality- and compliance-relevant activities in line with internal regulations, good practices, legislation, and regulatory/Novartis requirements. </li><li>Contribute to risk management, inspection readiness, quality management activities, and end-to-end management of internal and external quality-related projects. </li></ul><p></p><p><b>Essential Requirements</b>:</p><p></p><ul><li>University degree in pharmacy, chemistry, biology, microbiology, veterinary medicine, or another relevant natural or engineering science. </li><li>PhD in a relevant discipline preferred, especially for senior/expert roles. </li><li>Solid experience in analytical methods (development, validation, transfer) within a regulated environment (e.g., pharma, biotech). </li><li>Strong understanding of GxP, regulatory expectations, and quality systems. </li><li>Proven ability to interpret complex analytical data and produce clear, structured reports. </li><li>Experience with equipment qualification and management of analytical reference standards. </li><li>Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook). </li><li>Fluent in English (written and spoken); additional languages are an advantage. </li></ul><p></p><p></p><p><b>Commitment to Diversity and Inclusion / EEO paragraph:</b></p><p>Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.</p><p><b>Why Novartis:</b> Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? <a href="https://www.novartis.com/about/strategy/people-and-culture" target="_blank">https://www.novartis.com/about/strategy/people-and-culture</a></p><p><b>Join our Novartis Network:</b> Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: <a href="https://talentnetwork.novartis.com/network" target="_blank">https://talentnetwork.novartis.com/network</a></p><p><b>Benefits and Rewards: </b>Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: <a href="https://www.novartis.com/careers/benefits-rewards" target="_blank">https://www.novartis.com/careers/benefits-rewards</a></p><p></p><p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Skills Desired</b></p>Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management
Novartis
PHARMACEUTICAL
Small Molecules, Vaccines, Biologics / Diagnostics
LocationBASEL, Switzerland
Employees78,000
Open Jobs646
OncologyImmunologyNeuroscienceCardiovascularOphthalmology
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