Global Quality Control/Analytical Science and Technology Head

Role Summary

The Global Head of QC/AS&T leads the strategy and execution to ensure quality and consistency across all laboratories and analytical systems within the RLT platform. This role drives global standardization, lab performance improvements, and compliance through effective AS&T and QC organizations, working closely with site QC heads and platform peers. Approximately 25% travel is required.

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.

Qualifications

• 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.

Education

• Minimum degree in Pharmacy, Chemistry, Biology or related subject; MS preferred but not required.