Associate Director Process Excellence

vor 2 Wochen

Munich, Deutschland Novartis Vollzeit

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 Sandozare you ready to make a difference?
600 million - that's how many people suffer from asthma and COPD worldwide. Many of the innovative medicines are expensive. Sandoz is working hard to offer affordable generics for respiratory diseases.

**Your key responsibilities**:

- 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
- Drives/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 compliance projects and operational compliance tasks as assigned
- Leads process transformation/improvements as assigned: e.g. manages the automation of data collection for reporting, gathering and reviewing high quality and meaningful commentary and provide dashboards and regular management update reports to Senior Management. Present KPI data and insights to senior management and independently facilitate team / management meetings to discuss quality compliance and performance
- Leads the development of innovative solutions for effective tracking, management and oversight of key governance and compliance data (Metrics, Inspections, Escalations, Quality Issues, etc.)
- Deputize for Regulatory Operational Excellence Leadership at HA Inspections and Internal audits and fully represents the department in Health Authority inspections/interviews, if needed
- Ensures that the escalation process to next or higher level management is followed as applicable
- Facilitates/ leads Investigation/Deviation and CAPAS (including trending/monitoring and closure)
- Discloses risks related to regulatory and quality compliance, ensure risk communication/ escalation and mitigation
- Builds strong interface within RA functions and QA, but also towards Development, Pharmacovigilance, Medical and TechOps and consultancy to country organizations/other functions as required

**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._

**Minimum requirements**

**What you’ll bring to the role**:

- Scientific academic degree, preferably in life sciences (chemistry, pharmacy, biology, or equivalent qualifications)
- Good knowledge of English
- Extensive experience (7-10 years) in Regulatory Affairs and/or Quality functions, relevant professional experience in a similar Compliance Manager Profile in the areas of Quality, Compliance or Pharmacovigilance and/or Health Authority experience related to audits/inspections
- Cross-functional matrix leadership experience
- Organizational awareness and agility (interaction between functions, priorities)
- Strong interpersonal skills, project management, communication, negotiation skills and solution-oriented compliance and quality mindset

**Why Sandoz?**

500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 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.
How will we do this? 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 Sandoz
**Commitment to Diversity & Inclusion**:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

**Division**

SANDOZ

**Business Unit**

Sandoz Global Development

**Country**

Germany

**Work Location**

Holzkirchen (near Munich)

**Company/Legal Entity**

Hexal AG

**Functional Area**

Research & Development

**Job Type**

F

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