Analytical Manager in External Supply Organization

Posted Yesterday
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Grania, Barcelos, Braga
In-Office
Senior level
Biotech • Pharmaceutical
The Role
Lead analytical and stability activities in external manufacturing, ensuring compliance, quality assurance, and effective root cause analysis while managing and improving quality systems.
Summary Generated by Built In

Job Description Summary

#LI-Hybrid
Location: Barcelona, Spain
Join our team of experts driving analytical excellence across external manufacturing. In this role, you will own and evolve the ESO AS&T quality system, lead analytical and stability activities, and partner closely with external manufacturers. By applying strong scientific judgment and resolving complex analytical challenges, you will directly support product quality, supply reliability, and patient safety within a global network.
Relocation Support: This role is based in Barcelona, Spain. Novartis is unable to offer relocation support: please only apply if accessible.


 

Job Description

Key Responsibilities

  • Lead implementation and continuous improvement of the ESO AS&T quality system, tools, and analytical processes
  • Drive global AS&T programs and ensure compliance with internal standards, regulatory expectations, and data integrity requirements
  • Responsible for managing analytical changes and providing required assessments during general change control activities. Defines and oversees studies and evaluations necessary to support analytics-related changes
  • Own and maintain testing monographs, ensuring alignment with registrations, pharmacopeia standards, and state-of-the-art methods
  • Responsible for leading analytical transfer assessments and the implementation of new analytical methods
  • Lead and support ESO stability programs at external manufacturers, ensuring regulatory compliance and scientific robustness.  Interpret stability data, analyze trends, and define corrective actions addressing emerging stability or analytical issues
  • Manage and escalate analytical investigations, ensuring effective root cause analysis and implementation of appropriate CAPAs
  • Act as single point of contact for analytical topics in cross-functional ESO AS&T projects and external collaborations
  • Support supplier qualification, audits, Health Authorities response and inspection readiness, providing expert analytical input as required

Essential Requirements:

  • University degree in pharmaceutical sciences, chemistry, or another relevant natural science discipline
  • At least five years of professional experience, primarily in quality control within a regulated environment
  • Strong knowledge of analytical quality systems, stability programs, and analytical change management principles
  • Proven experience managing analytical investigations in compliance with current Good Practice standards
  • Ability to interpret complex analytical and stability data and draw scientifically sound conclusions
  • Fluency in written and spoken English, with the ability to communicate effectively across functions and cultures

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

Join 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/network

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

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Managing Resources, Organizational Savvy, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Smart Risk Taking, Technological Expertise, Total Quality Management

Top Skills

Analytical Quality Systems
Laboratory Equipment
Stability Programs
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The Company
HQ: Basel
110,000 Employees
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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