
Global Quality Control/Analytical Science and Technology Head
Our Take
Lead global QC strategy and digital transformation for Novartis' RLT platform, ensuring product quality and compliance.
What they’re looking for
- 10+ years GMP experience in Biotech QA/QC
- MS degree preferred in Pharmacy, Chemistry, Biology
- Solid FDA/EMA/ICH regulatory knowledge
- Broad cGMP experience
- English fluent, written and spoken
What you get
- Competitive salary
- Annual bonus
- Pension scheme
- Share scheme
- Health insurance
- 27 days annual leave
- Flexible working arrangements
- Learning and development opportunities
Skills & Focus Areas
- Quality Assurance
- GMP
- FDA
- EMA
- ICH
- cGMP
- Quality Control
- Leadership
As posted by Novartis AG
#LI-HybridThe 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. Major Accountabilities: 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 awarenessEnsure adherence to global and local safety and regulatory internal and health authority standards.Requirements:Minimum degree in Pharmacy, Chemistry, Biology or related subject; higher level degree: MS, preferred but not required. Additional knowledge in Quality Assurance / Compliance10+ years’ experience in GMP-regulated industries incl. QA/QC in Biotech area.Solid working knowledge of FDA/EMA/ICH regulatory requirementsBroad 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? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network: 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: https://talentnetwork.novartis.com/networkBenefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewardsYou 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.