Senior Expert

**Summary**:
About the role:
LI-Hybrid

We are seeking a highly motivated and experienced GMP Officer to support compliance activities and quality assurance processes across the Analytical Operations team in Austria (AO AT). As the GMP Officer you are coordinating and preparing inspections, assuring GMP compliance of all activities in the department and providing expert guidance on GMP compliance aspects including state-of-the art analytical technology and Data & Digital solutions. In addition, you lead quality-related strategic initiatives in alignment with the global Analytical Operations team.

**About the Role**:
**Key responsibilities**
- Act as first point of contact for all GMP/compliance related aspects for team members and stakeholders.
- Assure audit readiness of the department and facilitate audits and inspections, including self-inspections, global audits and Health Authority visits and manage Corrective & Preventive Actions (CAPAs) resulting from inspections.
- Lead local and global quality related strategic initiatives in alignment with the global Analytical Operations team.
- Provide GMP/compliance guidance on documentation, systems use, SOPs/WPs/Guidelines, including state-of-the art analytical technology (e.g. lab automation systems, mass spectrometry) and Data & Digital solutions (e.g. ELN).
- Track updates and manage the review/implementation of global and local SOPs in collaboration with Subject Matter Experts (SMEs).
- Train new team members on general GMP topics and Standard Operating Procedures (SOPs).
- Act as an investigator for quality related incidents and create trending reports for investigations, including OOX and deviations.
- Conduct regular spot-checks for lab systems, instrumentation, and processes. Author and review SOPs.

**Essential Requirements**:

- Master’s degree in biotechnology, biochemical engineering, biology, chemistry, biochemistry or similar with at least 4 years relevant industry experience or PhD in relevant field or equivalent and 2+ years of work experience within the pharmaceutical industry in a GMP regulated environment.
- Thorough knowledge of GMP, compliance regulations and quality assurance principles.
- Experience participating in audits and inspections.
- Certifications and hands-on experience with deviations, Data Integrity (DI), and CAPA processes are an advantage.
- Strong matrix leadership skills.
- Strong organizational and exceptional communication skills.

**Desirable requirements**:

- Proficiency in laboratory systems and reporting (e.g., 1QEM system, trending reports).

**You’ll receive**:
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 65,605.54 a year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.

**Adjustments for Applicants with Disabilities**

Division

Development

Business Unit

Universal Hierarchy Node

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Adjustments for Applicants with Disabilities**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.