Manager (d/f/m) Process Excellence / Regulatory Compliance

Novartis

Job title:

Manager (d/f/m) Process Excellence / Regulatory Compliance

Company

Novartis

Job description

Job Description

Manager (d/f/m) Process Excellence / Regulatory Compliance, Kundl, Austria

2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!

Together we will shape the future of Sandoz… are you ready to make a difference?

13! This is the number of departments we have in the new Sandoz Regulatory Affairs organization. Help us to bring our business processes and compliance to the next level to optimize our setup in the new Sandoz Regulatory Affairs function responsible for both Biosimilars and Generics. Join us as a Manager (d/f/m) in the Process Excellence team or the Regulatory Compliance team in our Regulatory Operational Excellence Group in Kundl with responsibility for all Sandoz Regulatory Affairs departments globally.

Your key responsibilities:

Your responsibilities include, but are not limited to:

  • Partners with other team members in Regulatory Operational Excellence and stakeholders within and outside Sandoz Regulatory Affairs to address potential quality issues, compliance topics, process improvements, and recommend solutions, providing backup support, as needed
  • Supports implementation and maintenance of a quality strategy, a quality management system with stakeholders to set up threshold for quality compliance in Sandoz Regulatory Affairs and work on process improvements and efficiencies
  • Leads/supports compliance projects and operational compliance tasks as assigned
  • Leads/supports process transformation/improvements as assigned
  • Leads/supports the development of innovative solutions for effective tracking, management and oversight of key governance and compliance data (Metrics, Inspections, Escalations, Quality Issues, etc.)
  • Support preparation and execution of regulatory tasks at HA Inspections and internal audits, if needed
  • Ensures that the escalation process to next or higher level management is followed as applicable
  • Facilitates/leads/supports investigation/deviation and CAPAS (including trending/monitoring and closure)
  • Discloses risks related to regulatory and quality compliance, ensure risk communication/ escalation and mitigation
  • Liaise with RA functions and QA, but also with Development, Pharmacovigilance, Medical and TechOps and consultancy to country organizations/other functions as required

Minimum requirements

What you’ll bring to the role:

Essential:

  • Scientific academic degree, preferably in life sciences (chemistry, pharmacy, biology, or equivalent qualifications)
  • Good knowledge of English
  • Experience in regulatory affairs and/or quality/compliance and/or operational excellence/process excellence

Desirable requirements:

  • Well-organized, excellent time management with respect to priorities and self-management
  • Strong interpersonal skills, project management, communication, negotiation skills and solution-oriented compliance and quality mindset
  • Experience in cross-functional matrix environment, international setting
  • Knowledge of regulatory processes and requirements

Why Sandoz?

Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Imagine what you could do here at Sandoz!

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.

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 € 60,212.18/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.

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

#Sandoz

Functional Area

Research & Development

Division

SANDOZ

Business Unit

Sandoz Global Development

Employment Type

Regular

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

Yes

Expected salary

Location

Kundl, Tirol

Job date

Sun, 02 Jul 2023 01:36:54 GMT

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