Group Head - Director Risk Management Drug Device Combination Products (f/m/d) (m/w/d)

Summary
#LI-Hybrid
Internal job title: Director Risk Mgmt & Control Strategy
Location: Schaftenau, Austria
With the increasing diversity of Novartis' portfolio, the need for understanding and managing technical and user risks and defining sound control strategies securing the quality of drug-device combination products is also increasing. As such, we are searching for a Group Head with risk management, combination product development and people management experience to lead the team and build the strategies.
As global leader of your team of experts and as member of the Competence Center lead team within Novartis' Global Device & Packaging Development organisation (GDPD) you ensure that all risk management and control strategy related activities are delivered for Novartis' drug delivery device and drug-device combination product development portfolio. You will also drive respective global strategies for Novartis.
About the Role
Key Responsibilities:
• 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 its justification, inline with Health Authority expectations (e.g. FDA's essential performance requirements), European Medical Device Regulation, and Quality-by-Design approaches like ICH Q12.
• This requires strong collaboration within GDPD organisation (e.g. with Packaging Development, Device Technology, Human Factors Engineering, Analytical Testing) 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 and related x-functional high-impact strategic initiatives, 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 extensive working experience in pharmaceutical industry including technical development of injectables and/or drug-device combination products.
• Excellent skills in leading people and projects in global, interdisciplinary and cross-cultural environment
• 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.
• Proficiency in English (written and spoken)
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 € 8 5,704.64 /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.
A djustments 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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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