Quality Manager, Third-Party Management

Novartis AG

Schaftenau

Hybrid

EUR 67,000 - 105,000

Full time

2 days ago
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Benefits offered by this job

Flexible and hybrid working options
14 weeks paid parental leave
Insurance plans
Retirement plans
Wellbeing resources
Global recognition programs

Job summary

Novartis AG in Schaftenau, Austria, seeks a Quality Manager for Third Party Management to oversee global TRD outsourcing activities from onboarding to full supplier lifecycle.

You will ensure cGMP compliance, provide quality oversight of external partners, and contribute to global Third-Party QA processes, risk assessments and continuous improvement initiatives, while collaborating across TRD and Quality units.

Qualifications

  • Master’s degree in a relevant scientific or technical discipline.
  • Bachelor’s degree with more than five years of pharmaceutical industry experience.
  • Strong knowledge of cGMP and GMP compliance.
  • Experience in quality oversight of external partners.

Responsibilities

  • Support global outsourcing projects in the Third-Party QA role through the full lifecycle.
  • Evaluate third-party compliance status and support approvals and ongoing oversight.
  • Negotiate and finalize Quality Agreements with third parties.
  • Execute risk assessments and track performance for continuous monitoring.
  • Create and maintain SOPs, QA templates and global standards.
  • Lead or support global Third-Party Management initiatives and quality plans.
  • Act as investigator or approver for deviations and changes in quality systems.

Skills

Business Partnerships
Collaboration
Communication
CAPA
Data Integrity
Digital Fluency
GMP
Inspection Management System
Managing Ambiguity
Operational Excellence
Performance Auditing
Problem Solving
Quality Assurance
Quality Compliance
Quality Management
Quality Management Systems
Regulatory Compliance
Stakeholder Management
SOP

Education

Master’s degree in a relevant scientific or technical discipline
Bachelor’s degree with >5 years pharma experience

Job description

Salary Range: €66,918.00 - €105,200.00

Job Description Summary

Role Type: Hybrid Working, #LI-Hybrid

Location: Schaftenau, Austria

Relocation Support: This role is based in Schaftenau, Austria. Novartis is unable to offer relocation support: please only apply if accessible.

As Quality Manager, Third Party Management, you will support global Technical Research and Development outsourcing activities from third-party onboarding through the full supplier lifecycle. You will help maintain current good manufacturing practice (cGMP) compliance, provide quality oversight of external partners, and contribute to global Third-Party QA processes, risk assessments and continuous improvement initiatives.

Job Description Key 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 (TRD) outsourcing strategy.
  • Evaluate the compliance status of third parties 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, Novartis procedures and applicable health-authority requirements.
  • Execute third-party quality risk assessments and performance tracking to enable continuous monitoring, early identification of negative trends, remediation planning, and escalation where required.
  • Create and maintain Standard Operating Procedures (SOPs), Quality Agreement templates and related documents that set 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 investigator or approver for deviations, and as change originator, owner or approver within the relevant quality systems.
Essential requirements
  • Master’s degree in a relevant scientific or technical discipline, or a bachelor’s/technical qualification with more than five years of pharmaceutical industry experience.
  • Good knowledge of current cGMP and demonstrated ability to assess and evaluate GMP compliance.
  • Experience in technical development, pharmaceutical production or Quality Assurance.
  • Sound scientific, technical, and regulatory knowledge relevant to pharmaceutical development and external quality oversight.
  • Strong organisational, analytical, and decision-making skills, with the ability to manage activities against agreed timelines and standards.
  • Fluent written and spoken English; proficiency in the relevant local site language is desirable.
What you will bring

You will be comfortable working independently on projects of lower to moderate complexity while contributing to more complex projects with appropriate mentoring. You will collaborate across TRD line functions and Quality units, promote consistent application of the Novartis Quality Manual and external regulatory expectations, and provide pragmatic quality support to project teams and external partners.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people working together, collaborating and inspiring each other to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Benefits & Rewards
  • Expected Annual Base Salary Range for role: €66,918 to €105,200
  • The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
  • In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
  • The rewards of being part of our team go far beyond base pay and incentives.
  • We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
  • In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Skills Desired
  • Business Partnerships
  • Collaboration
  • Communication
  • Corrective and Preventive Action (CAPA)
  • Data Integrity
  • Digital Fluency
  • Good Manufacturing Practices (GMP)
  • Inspection Management System
  • Managing Ambiguity
  • Operational Excellence
  • Performance Auditing
  • Problem Solving
  • Quality Assurance (QA)
  • Quality Compliance
  • Quality Management
  • Quality Management Systems (QMS)
  • Regulatory Compliance
  • Stakeholder Management
  • Standard Operating Procedure (SOP)

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

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