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Novartis

Global pharmaceutical company delivering science-based innovations

Quality Manager - Third-Party Management

Regulatory & Quality (Life Sciences)Posted on Nov 11
Full-timeLangkampfen, Austria

About the Job

Requirements

  • A relevant scientific or technical master's degree, or a bachelor's degree or technical qualification plus more than five years of pharmaceutical industry experience.
  • Good knowledge of current good manufacturing practice and the ability to assess and evaluate good manufacturing practice compliance.
  • Experience in technical development, pharmaceutical production, or Quality Assurance.
  • Scientific, technical, and regulatory knowledge relevant to pharmaceutical development and external quality oversight.
  • Ability to manage activities against agreed timelines and standards.
  • Fluent written and spoken English.

Responsibilities

  • Support global outsourcing projects in the Third-Party QA role, from onboarding through the full third-party lifecycle, in alignment with the global Technical Research and Development outsourcing strategy.
  • Evaluate third parties' compliance status and support their approval and ongoing quality oversight, including monitoring assessment due dates and required follow-up actions.
  • Establish, negotiate, and secure final signatures for Quality Agreements with third parties, aligned with technical agreements, audit reports, company procedures, and applicable health-authority requirements.
  • Execute third-party quality risk assessments and performance tracking to support continuous monitoring, early identification of negative trends, remediation planning, and escalation where required.
  • Create and maintain Standard Operating Procedures, Quality Agreement templates, and related documents that establish consistent global standards for Third Party Management.
  • Lead or support global Third-Party Management initiatives, including global meetings, improvement projects, new processes, quality plans, and quality-risk activities.
  • Act as an investigator or approver for deviations, and as a change originator, owner, or approver within the relevant quality systems.
  • Work independently on projects of lower to moderate complexity and contribute to more complex projects with appropriate mentoring.
  • Collaborate across Technical Research and Development line functions and Quality units, promote consistent application of the Quality Manual and external regulatory expectations, and provide pragmatic quality support to project teams and external partners.

Desired Qualifications

  • Proficiency in the relevant local site language.
  • Strong organisational, analytical, and decision-making skills.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

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