Global Head QA Operations Aseptics

Job Description Summary

The Global Head of QA Operations lead and supervise the Quality Units in the assigned sites (Aseptic Drug Product, Cell&Gene Therapies) to ensure they are operating in compliance to international cGMP standards, Novartis rules and applicable market regulatory requirements. Provide guidance and support to the Site Quality in critical quality decisions, ensuring support and oversight with regards to budget, headcounts, people and organizational development. Support assigned projects. The Global Head of QA Operations is a permanent member of the ADP Platform Quality Leadership Team

 

Job Description

Major Accountabilities:

• Coordinate and support the Quality Units, ensuring implementation and continuous development of Quality systems and programs, performance monitoring.
• Evaluate Quality performance (KPIs and Quality reporting), report progresses and issues to QA management and ensure appropriate and timely follow up on action plans and programs successfully through preparation, execution and follow-up of health authority inspections and to determine trends and opportunities for continuous quality improvement
• Support in TpT and OTBA initiatives (NOSCEE SPOC), ensuring alignment with global standards
• Provide guidance to ensure continuous organizational improvement and development to drive Operational Excellence & better financial outcomes
• Drive harmonisation and process improvements initiatives across sites
• Act as Supply QA contact and support Annex 16 clarifications
• Responsible to ensure Artwork problems are adequately managed and follow up measures are implemented
• Coordinate and support Supplier certification program
• Perform compliance checks in site and support escalation process
• Support quality escalation processes, ensuring timely communication and robust resolution of critical quality events

Obligatory requirements:

• Education: Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science.   
• 15 years of experience in manufacturing of biopharmaceuticals drug products and Quality Assurance.
• Operational knowledge of aseptic processing and medical device quality requirements.
• Excellent GMP knowledge and aseptic environments.
• QA / QC knowledge and solid experience with Authorities´ inspections.
• Fluent English, written and spoken.

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-culture

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Benefits 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-rewards

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.

 

Skills Desired