QA Compliance Expert

**Summary**:
QA Compliance Expert is responsible for managing cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators). Performs preparation and management of external and corporate audits and Health Authority inspections.

**About the Role**:
**Major accountabilities**:

- Supplier, technical service provider and contractor management/qualification (quality agreements, oversight, audit, medical device) including planning and surveillance of audit plans
- Establishment, maintenance and oversight of Quality Assurance Agreements affecting Drug Product Schaftenau (medical device); Audit and inspection preparation and support
- Ensure supplier-, contractor
- and internal/HA/customer management in 1QEM as audit coordinator, preparation and performance of self-inspections
- Implementation of Quality Systems (incl. documentation management)
- Preparation/support and coordination of CAPA/follow-up and alert-/gap-/risk assessments; KPI / KQI reporting and trending
- Change control review/approval; ensure local deviation management; ensure process quality assurance acc. to regulations and supports local project-/regulatory management and Site Master File preparation
- Support communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country

**Minimum Requirements**:

- University education in natural sciences, chemistry, biology or similar
- At least 3 years or more experience in QA Experience in operations management and execution
- Knowledge of GMP required
- Preferably experience in negotiations and global collaboration
- Fluent knowledge of English and German language (written and spoken)
- Flexibility to work in a fast paced, quickly changing work environment
- Ability to operate in a global matrix environment

**Why Novartis?**

**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/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.

We are open for part-time and job-sharing models and support flexible and remote working where possible.

**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:
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Division

Operations

Business Unit

Innovative Medicines

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Quality

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.