Quality Team Leader QA Operations

vor 6 Monaten

Langkampfen T, Österreich Novartis Vollzeit

390704BR

**Quality Team Leader QA Operations (M/F/d)**:
Austria

**About the role**

**Quality Team Leader QA Operations (M/F/d), Drug Substance, Schaftenau**

As Quality TL QA Operations you will be providing the Leadership in all quality related matters to ensure that all aspects of the operational business comply with cGMP (Current Good manufacturing Practices) legal and regulatory requirements and the Novartis Quality Manual & Policies. You will be ensuring that all products manufactured by site/External Supplier in addition to the imported products for local site are released to the market according to Novartis Quality Standards.

**Your key responsibilities**:
Your responsibilities include, but are not limited to:

- Oversight of Quality Operations across site; MBR review and approval; product release
- QA for Quality Control and AS and T; QA Operational Excellence; line responsibility and daily walkthrough; lead OpEx Projects; Investigation of Deviation, OOx, Complaints
- Define and implement CAPAs; support transfer Projects & validation studies; track team metrics and ensure KQI /KPI meet requirements
- HSE incidents reporting and action follow up; new equipment commissioning Support (OQ, PQ); define improvement areas in process and products; ensure availability of equipment, chemicals and consumables, AS appropriate; SOP review and revision
- Resource and capacity (people and equipment) planning and workload management; performance and leadership Support to specialist team; initiate and drive local hiring process; ensure onboarding and training of new team members and provide similar support to new team members of other teams as appropriate; perform local training and monitor training status
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt; distribution of marketing samples (where applicable)
- Target / KPI setting according to the global target letter; no KPI misses caused by QA Operations
- Participate in and ensure implementation of efficiency and saving projects; ensure timely batch release in the responsibility of QA Operations and participate in continuous improvement projects to shorten the overall batch release through put time

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Role Requirements**

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

- University degree in chemistry, biology, pharmacy, or related field
- min 5 years of experience in pharma industry, preferable in QA und QC Operations
- Proficiency in English and German (spoken & written)
- Leadership experience
- Good communications skills
- Strong background in phys-chem analytics pf proteins and nucleic acids.
- Very experienced in leading larger organisations

**Why Novartis?**

**Imagine what you could do here at Novartis**

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities 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 €73,112.90/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 work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

**Join our Novartis Network**:
**Division**

Operations

**Business Unit**

QUALITY

**Work Location**

Schaftenau

**Company/Legal Entity**

NVS Pharmaceutical Manu. GmbH

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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