QA Compliance Expert

393594BR

**QA Compliance Expert - Reg CMC Facilitator**:
Austria

**About the role**

**QA Compliance Expert - Reg CMC Facilitator**

Supporting product maintenance, and activities throughout the product life-cycle using regulatory strategies and documents related to CMC (Chemistry, Manufacturing & Control). This applies to sector-specific (global and local) products and is intended to ensure timely market supply in compliance with regulatory requirements.
Supporting change - and inspection management within the QA Compliance Team.
**Your key responsibilities**:
Your responsibilities include, but are not limited to:

- Maintaining close cooperation with RA CMC to discuss regulatory requirements, strategies and knowledge of global product dossiers to stay up-to-date.
- Conducting training to ensure appropriate knowledge and regulatory compliance.
- Supporting the area in effective change control. Examination of reg. relevance and pre-evaluation amendments to Novartis products and customer products.
- Contact person for regulatory matters and intermediary between RA CMC and production unit at strategy decisions and in the product life cycle.
- Support of timely reviews of CMC documents for defined products; Support with and Identification of challenges in the course of regulatory compliance audits.
- Implementation and overview of initiatives to improve (regulatory) compliance.
- Coordination, guidance, and support in the preparation of CMC responses to health authorities for specific products.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

**What you’ll bring to the role**:
**Essential**:

- Advanced University or academic degree in chemistry, biology, pharmacy, engineering or equivalent.
- Fluent English (German desired).
- More than 3 years of experience in an operational GxP area, in Manufacturing, Development or QA or Regulatory Affairs; with a thorough knowledge of biologic drug substance manufacturing processes for recombinant proteins and/or nucleic acids.
- Ability to speak up and to take Quality decisions during challenging situations.

**Desirable requirements**:

- Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership, and project management experience.
- Ability to work independently and effectively in international, complex, and multifaceted environments.

**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 € 60,212.18/year (on a full-time basis). In most cases, the actual salary will be 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**:
**Join our Novartis Network**:
**Division**

Operations

**Business Unit**

QUALITY

**Work Location**

Kundl

**Company/Legal Entity**

NVS Pharmaceutical Manu. GmbH

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes