QA Operations Lead

**QA Operations Lead (f/m/d), Quality Large Molecules, Drug Product Schaftenau, Austria**

Nr. 1 Take the lead in making Drug Product Schaftenau to be the nr. 1 fill finish site for biologics within Novartis Operations
A QA Operations Lead is responsible to ensure compliance to cGxP standards for our product portfolio and for product release as well as to provide guidance, support and leadership to teams within the area of responsibility.

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

- Leading the QA Operations group consisting of the units of Qualified Persons; QA Experts, QA Specialists and QA SAP Experts
- Driving the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operational requirements and supports a robust career path deployment and succession plan for area of responsibility
- Assuring GMP compliance of batch manufacturing and taking usage decision for batches
- Providing operational and technical leadership for the QA Operations group in all quality and cGMP compliance related matters and ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements and Novartis Quality Manual requirements
- Participating as key function in operational site processes like approval of specifications, sampling instructions, test methods and other quality control procedures
- Ensuring the review of Batch Manufacturing Records and Batch Testing Records by groups of QA Specialists and Experts
- Performance and approval of investigations of major/critical deviations, OOS/OOE and complaints, CAPAs and Risk Assessments
- Representing QP group in evaluation of changes to processes and specifications and participation in the compilation and approval of validations, transfers and SOPs
- Preparation for and participation in audits and inspections
- Guide the QA Ops team in improving existing processes and procedures to further develop and maintain the quality system

**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**:
**Essential**:

- Advanced University or academic degree in chemistry, biology, pharmacy, engineering or equivalent
- Fluent (oral and written) in English, German desired
- Minimum of 5-7 years’ experience in an operational GxP area, in Manufacturing, Development or QA; with a thorough knowledge in aseptic filling operations and releasing medicinal products
- Profound experience leading large team in quality
- Ability to speak up and to take Quality decisions during challenging situations
- Strong leadership skills with excellent interpersonal, communication and negotiation abilities, with confirmed experience in change management and integration of teams and/or organizations
- Proven inspection track record with FDA, EMA, and other Health Authority inspections
- Passion for people coaching and development

**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?**

769 million lives were touched by Novartis medicines in 2020, 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 €66,526.88/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 Dive