Summary
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The Global Head RLT QC / AS&T plays a crucial role in ensuring the quality and consistency of our products throughout their lifecycle. This role encompasses a wide range of responsibilities for the execution of strategy and the integration of all strategic and operational initiatives to ensure consistent and aligned standards across all laboratories, laboratory performance (\"lean labs\") and compliant analytical systems with competent and effective AS&T and QC organizations in the RLT Platform. Acting in accordance with legislation, internal regulations, good practices and business goals. It is a key leadership position as part of the RLT Quality leadership team working closely with Site QC heads as well as other platform QC / AS&T communities.
About The Role
Approximately 25% travel required.
Major Accountabilities
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* Leading the implementation of a QC strategy, including method lifecycle strategy, global laboratory digital strategy, new method strategy, to increase the compliance and efficiency of QC laboratories in the RLT organization.
* Enforcing global standardization/integration of business processes and information, data, global equipment standards and application architecture.
* Enforcing the QC/AS&T action plan by defining and implementing appropriate roadmaps for QC/AS&T teams across the platform, ensuring compliance, continuous improvement and increasing the effectiveness of all types of QC testing. Initiating, implementing and sustaining initiatives defined by global QC/AS&T.
* Ensuring and promoting cross-site collaboration and transparency of joint initiatives, problems and lessons learned.
* Supporting the development of on-site platform/team members in technical and leadership skills. Coaching and people development. Delivering training programs developed by the global QC/AS&T function and actively participating in the development of relevant learning materials.
* Proactively provide strong QA leadership to the business by ensuring considerable quality and organization awareness.
* Ensure adherence to global and local safety and regulatory internal and health authority standards.
Requirements
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* Minimum degree in Pharmacy, Chemistry, Biology or related subject; higher level degree: MS, preferred but not required. Additional knowledge in Quality Assurance / Compliance.
* 10+ years’ experience in GMP-regulated industries incl. QA/QC in Biotech area.
* Solid working knowledge of FDA/EMA/ICH regulatory requirements.
* Broad cGMP experience with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
* Ability to synthesize detailed information and provide clear communication and messaging across quality, manufacturing and supply chain.
* English Fluent, written and spoken. Other languages are a plus.
Why Novartis
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? xjrgpwk our Novartis Network
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Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: will receive
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 27 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Read our handbook (PDF 30 MB)
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