Compliance and Operations Manager

hace 3 meses

Barcelona, España Novartis A tiempo completo

391631BR

**Compliance and Operations Manager - Epidemiology**:
Spain

**About the role**

**Location**: Barcelona or Madrid (Hybrid)
The Compliance & Operations Manager enables quality and operational oversight of regulatory commitments and compliance with relevant research policies including managing the scientific, operational and technical quality review process for Quantitative Safety & Epidemiology’s (QSE) deliverables. This role is part of the QSE team and reports to the Global Head QSE.
**Key Responsibilities**:

- Independently organize the operations, planning and contracting with external partners for QSE non-interventional studies (NIS).
- Develop tools and training to track compliance with Novartis SOPs and with the scientific and technical quality review process within QSE.
- Track audit readiness of QSE deliverables, including maintenance of Trial Master File with required documents.
- Develop innovative ideas/plans (e.g., automated tools) for compliance with Novartis SOPs and policies based on a comprehensive knowledge of non-interventional safety study requirements. Collaborate with relevant line functions including RWE-generating functions, QA, procurement, Global Development Operations (GDO), legal, and External Development Operations (EDO) for operational effectiveness and excellence.
- Create metrices for tracking the status of NIS to support study update presentations to PS & PV leadership.
- Track QSE initiatives and achievements over the year.
- Drive continuous process optimization and simplification to improve QSE productivity and overall performance.
- Lead project management support for QSE NIS and QSE innovative projects.

**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._

**Role Requirements**

**Key Requirements**:

- Fluent English (both spoken and written)
- Bachelor’s degree minimum, Master’s degree in public health, healthcare, management or administration preferred
- Sufficient experience in positions with increasing relevant responsibilities in the Pharmaceutical Industry
- Experience coordinating global projects and leading contracting efforts required
- Expert understanding of compliance requirements for non-interventional safety studies (including associated analyses) and needs for inspection readiness
- Strong organizational, project management, and implementation skills and experience. Ability to break down complex projects into simple parts
- Ability to build strong working relationships with internal and external collaborators across multiple areas
- Excellent knowledge of reporting procedures and record keeping
- In-depth knowledge of the industry’s standards and regulations

**Desirable Skills**:

- Experience within Epidemiology

**Division**

Development

**Business Unit**

Patient Safety & Pharmacovigilance

**Work Location**

Barcelona Gran Vía

**Company/Legal Entity**

Novartis Farmacéutica, S.A.

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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