Quality Manager, Third-Party Management
Novartis
- Location
- Schaftenau
- Source
- workday
Salary Range:
€66,918.00 - €105,200.00Band
Level 4Job Description Summary
Role Type: Hybrid Working, #LI-HybridLocation: 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
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
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)