Quality Assurance Compliance Expert (m/w/d)

DTX Pharma, a Novartis Company; Osterreich; Sur place; PEN 258 000 - 406 000; Plein temps

Avantages offerts par ce poste

Flexible working options

Hybrid work options

Résumé du poste

Novartis Austria is seeking a QA Compliance Expert to strengthen change control and quality systems, support audits and health authority inspections, and drive improvements. You will guide teams in electronic quality management systems and collaborate across functions to ensure medicines meet high quality standards.

The role requires a university degree in sciences, 3+ years in GMP, and fluency in English with German at least at a medium level.

Qualifications

• University degree in natural sciences, chemistry, biology, or a comparable field.
• 3+ years of experience in the pharmaceutical industry and GMP environments.
• Practical knowledge of quality assurance and compliance audit processes.
• Proficiency with information technology applications and electronic quality management tools.
• Strong project management, organization, decision-making, and communication skills.
• Fluency in English and at least medium level of German, with the ability to collaborate across stakeholders.

Responsabilités

• Coordinate site change control activities and lead the change review board.
• Manage customer change notifications with clarity, accuracy, and timely follow-through.
• Guide users and deliver training on electronic quality management systems.
• Support deviation reports, CAPA processes, and quality event processes.
• Prepare for and support compliance audits and health authority inspections.
• Monitor KPIs and quality indicators, address gaps and support compliance.
• Lead quality management projects focused on process optimization and QMS implementation.
• Support contractor oversight, product quality reviews, risk assessments, and regulatory submissions.

Connaissances

Project management

Organization

Decision-making

Communication skills

English fluency

German proficiency (medium)

Formation

University degree in natural sciences or related field

Outils

Electronic quality management tools

Description du poste

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

Band
Level 4

Job Description Summary
#LI-Onsite

Location: Schaftenau, Austria

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

Ready to turn quality expertise into meaningful impact for patients? As QA Compliance Expert (m/f/d), you will strengthen change control and quality systems, support audits and health authority inspections, and help ensure medicines meet high quality standards. You will collaborate across teams, guide colleagues in electronic quality management systems, and drive process improvements within an open, professional, and supportive environment.

Job Description

Deadline for applications: 29th October 2026.

Major Accountabilities

• Coordinate site change control activities and lead the change review board.
• Manage customer change notifications with clarity, accuracy, and timely follow-through.
• Guide users and deliver training on electronic quality management systems.
• Support deviation reports, corrective and preventive actions, and quality event processes.
• Prepare for and support compliance audits and health authority inspections.
• Monitor key performance and quality indicators, addressing gaps and supporting compliance.
• Lead quality management projects focused on process optimization and effective quality system implementation.
• Support contractor oversight, product quality reviews, risk assessments, and regulatory submissions.

Essential Requirements

• University degree in natural sciences, chemistry, biology, or a comparable field.
• 3+ years of experience in the pharmaceutical industry and Good Manufacturing Practice (GMP) environments.
• Practical knowledge of quality assurance and compliance audit processes.
• Proficiency with information technology applications and electronic quality management tools.
• Strong project management, organization, decision-making, and communication skills.
• Fluency in English and at least medium level of German, with the ability to collaborate across stakeholders.

Novartis Austria is one of the most modern and innovative manufacturing sites in the Novartis network. The sites in Tirol have approximately 3,500 employees and there are approximately 350 employees in the marketing & sales office in Vienna.The site in Tirol is in the middle of the Austrian Alps with excellent infrastructure.

Benefits & Rewards

In accordance with Austrian law, we are obliged todisclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 65,605.54 EUR/year (on a full-time basis).In most cases, the actual salary will be higher, aswe strive to maintain a competitive position in the market and consider your previous experience,qualifications, and individual competencies.

Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

The rewards of being part of our team go far beyond base pay and incentives.We also offer a variety of competitive benefits inkindto help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeingresourcesand global recognition programs. In addition, we provide flexible and hybrid working options, where possible, anda minimum of14 weekspaid parental leave.

Expected Annual Base Salary Range for role: EUR 66,918 – 105,100.

The 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. Further details will be provided during the application process.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

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.

Accessibility and Accommodation

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [e-mail] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

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

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

Skills Desired

Collaboration, Communication, Continuous Improvement, Data Integrity, Decision Making, Good Manufacturing Practices (GMP), Leadership, Managing Ambiguity, Operational Excellence, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Inspections, Quality Management Systems (QMS), Regulatory Compliance, Statistical Process Control (SPC), Supplier Quality Management