Global Quality Control/Analytical Science and Technology Head

Novartis•Indianapolis, IN

1d•Hybrid

About The Position

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. Approximately 25% travel required.

Requirements

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.

Nice To Haves

higher level degree: MS, preferred but not required.
Other languages are a plus.

Responsibilities

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.