QA Operations Expert (m/f/d)

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Schaftenau; Hybrid; EUR 67.000 - 105.000; Vollzeit

Benefits dieser Stelle

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

14 weeks parental leave

Zusammenfassung

Novartis in Schaftenau, Austria, seeks a QA Operations Expert. You will provide hands-on quality oversight across Drug Product manufacturing to safeguard regulatory compliance and product quality.

Your role supports investigations, audits, product transfers and continuous improvements to ensure reliable supply of medicines. The position requires a university degree in a scientific field and at least two years in QA/QC within pharma, with strong GMP experience and fluency in English and German.

Qualifikationen

• Essential Requirements: University degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology, or a comparable scientific field.
• Minimum of two years of professional experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Experience in a regulated GMP environment for Drug Product or biopharmaceutical products.
• Strong communication and presentation skills with cross-functional stakeholders.
• Fluency in English and German, both written and spoken.

Aufgaben

• Provide quality oversight for Drug Product manufacturing, ensuring compliance with regulatory and Novartis quality standards.
• Ensure site adherence to GMP and timely implementation of corporate quality requirements.
• Lead and approve deviation and out-of‑expectation investigations with root cause analysis.
• Release incoming DS and bulk batches, acting as Kontrolllaborleiter/in per AMBO and approve documentation.
• Approve manufacturing records and quality documentation to support product release and supply continuity.
• Support transfer of new products to the commercial Drug Product site.
• Participate in and support audits, ensuring inspection readiness.
• Approve specifications, test methods, and quality procedures; assess changes to processes and standards.

Kenntnisse

Collaboration

Communication

Quality Assurance

Quality Control

GMP

Decision Making

Leadership

Regulatory Compliance

Data Integrity

English & German

Ausbildung

University degree in Pharmacy or scientific field

Jobbeschreibung

Job Description Summary #LI-Hybrid

Salary Range: 66.918,00 € - 105.200,00 € Band Level 4

Location: Schaftenau, Austria

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

At our Schaftenau site, quality is not a function — it is a commitment to patients worldwide. As a QA Operations Expert, you will play a pivotal role in safeguarding the quality and compliance of Drug Product manufacturing, ensuring that every product manufactured on site meets the highest regulatory and Novartis quality standards. You will provide hands‑on quality oversight across manufacturing activities, act as a trusted partner to operations, and drive a strong quality mindset in a regulated Good Manufacturing Practice environment. By supporting investigations, audits, product transfers, and continuous improvement initiatives, your work will directly contribute to reliable product supply and timely availability of medicines that make a real difference to patients’ lives.

Key Responsibilities

• Provide quality oversight for Drug Product manufacturing, ensuring compliance with regulatory and Novartis quality standards.
• Ensure site adherence to Good Manufacturing Practice and timely implementation of corporate quality requirements.
• Lead and approve deviation and out‑of‑expectation investigations to ensure robust root cause analysis.
• Release incoming DS and internally produced bulk batches, acting as Kontrolllaborleiter/in according to AMBO Review and approve manufacturing, quality control, and technical documentation supporting compliant production activities.
• Approve manufacturing records and quality documentation to support product release and supply continuity.
• Support transfer of new products to the commercial Drug Product manufacturing site.
• Participate in and support internal and external audits, ensuring inspection readiness.
• Approve specifications, test methods, and quality procedures; assess and support changes to processes and standards.

Essential Requirements

• University degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology, or a comparable scientific field.
• Minimum of two years of professional experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Proven experience working in a regulated Good Manufacturing Practice environment for Drug Product or biopharmaceutical products.
• Strong communication and presentation skills, with the ability to engage effectively with cross‑functional stakeholders.
• Demonstrated accountability, sound decision‑making, and a structured, quality‑focused working style.
• Fluency in English and German, both written and spoken.

Desirable Requirements

• Experience with batch release activities and GMP release processes, ideally within packaging materials, drug substance or drug product manufacturing.

Rewards

• Insurance plans, retirement plans, wellbeing resources and global recognition programs.
• Flexible and hybrid working options, where possible.
• Minimum of 14 weeks paid parental leave.

Expected Annual Base Salary Range for role: 66.918,00 - 105.200,00 EUR 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.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Adjustments for Applicants with Disabilities: 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.

Commitment to Diversity and Inclusion / EEO paragraph: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

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

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.