Global Head of QA Operations, Lmo

vor 1 Tag

Langkampfen T, Österreich Novartis Vollzeit

**28,000** associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
- In the role you will lead and supervise quality operations related activities escalated to global level across all manufacturing sites in scope of responsibility as well as ensure implementation of quality operations related projects/programs, completeness of all related documentation and provision of on-site support in the course of Health Authority inspections (preparation, execution and response). You will ensure that all operational QA units across the sites in scope comply with international cGMP standards, Novartis rules and applicable market regulatory requirements.**Your key responsibilities**:

- You will lead, provide advice & guidance and supervise Quality operational Units, their budgets and personnel and Quality Projects across sites within responsibility.
- Ensuring implementation of global Quality standards and principles in sites in scope, continuous development of Quality systems and programs, GXP training, performance and productivity.
- You will represent the platform in all escalation cases relevant for the sites in scope and ensure that compliant measures are taken and effective CAPAs are defined.
- Ensure that sites are implementing cGMP-compliant processes & harmonized standards in line with Quality Manual, Global Operating Procedures and applicable Health Authority Regulations.
- You will Ensure Global QA-coverage for launches with focus on regulated markets.
- Leading the QA Operations network for the sites in scope.
- Steering Quality performance (KPIs and Quality reporting) in the assigned area, report progresses and issues to management and ensure appropriate and timely follow up on action plans and programs to determine trends and opportunities for continuous quality improvement.

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**

**What you’ll bring to the role**:

- University degree in Chemistry, Pharmacy, Biotechnology, Biology or another related science. PhD is desirable.
- 15 years experience in operational and leadership roles in the pharmaceutical industry, preferably in QA Operations (e.g. Quality Control, Microbiology, QA Operations), Manufacturing or experience as Site Quality Head.
- Thorough knowledge of cGMP requirements, proven track record with FDA, EMEA and other Health Authorities, good knowledge of the pharma market, customers and competition. Experiences with Quality Assurance / cGMP regulations in USA, EU (Self Inspections, Auditing of 3rd parties, Complaint/Deviation Handling, GMP-Training, SOP-Systems).
- Strong leadership, cross-country and multicultural experience.
- Strong understanding of risk assessment and risk management fundamentals/tools.
- Mandatory experience in sterile manufacturing and capable of being registered as a Qualified Person (QP) in the European Union.
- Fluent English language (written and spoken) required, German is a plus.

Possible job locations: Austria, Slovenia, Czech republic, Spain or Poland.**You’ll receive**
Flexible working schedule, competitive compensation package, annual bonus, possibility to work from home and many other benefits, related to the legal entity you’ll be employed at.
- .
- **Why Novartis?**
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
- We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying**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 € 73.187,94/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 (relevant only for Austria).
- Commitment to Diversity & Inclusion
- Novartis

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