Group Head – Associate Director Risk Mgmt Drug Device Combination Products (f/m/d)

As leader of your team of experts and as member of the competence center lead team you ensure that all risk management and control strategy related activities are delivered for Novartis’ drug delivery device and drug-delivery combination product development portfolio. You will also drive respective global strategy for Novartis.

Key Responsibilities:

Your responsibilities include but are not limited to:

• Leading a team of experts you ensure that technical (design and manufacturing) and use-related risks are identified, assessed and mitigated for the Novartis’ device and combination product development portfolio of Biopharmaceutical, RNA, small molecule, radioligand, cell & gene therapy drugs.

• You ensure state-of-the-art and harmonised control strategies securing product quality, e.g. testing / not testing at various product stages and the justification, which are understood and accepted by Health Authorities and are inline with QbD (Quality by Design) approaches like ICH Q12.

• This requires strong collaboration within GDPD organisation (Global Device & Packaging Development, Device & Packaging Technology and Human Factors Engineering) and with partners like Technical Operations, Clinical Development, Drug Development.

• You develop and support your team for best possible performance short- and long-term, you support your team in challenging projects and for strategic presentations as needed.

• You drive further development of high-quality efficient and effective approaches and processes for risk management and control strategy, inline with Novartis and external requirements, at the forefront of / shaping future approaches.

• You act proactively in building the culture to enable high employee engagement; seek for diversity and a high performing, supportive team • You contribute to and review regulatory documents, supporting product registrations and presenting at inspections.

Essential Requirements:

• Master or PhD in engineering or pharmaceutical field or equivalent and minimum 8 years’ experience in pharmaceutical industry in technical combination product development.

• Leadership experience in leading people and/or global projects.

• Proven knowledge in risk management and control strategy

• Understanding and awareness of regulatory guidelines for combination products, including relevant ISOs and current good manufacturing practices (cGMP). • Collaborative spirit, self-driven attitude, high level of learning agility, listener, strategic, interested in people development. • Fluent in English (oral and writing)

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture.

You’ll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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 €95,271.68/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:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network