Associate Director External Service Providers

vor 5 Monaten

Munich, Deutschland Novartis Vollzeit

385055BR

**Associate Director External Service Providers Quality (d/f/m)**:
Germany

**About the role**

**Location**:Holzkirchen, Germany #hybrid
As an Associate Director of External Service Providers (ESP) Quality Assurance, you will be contributing to Novartis Global Development for selection and qualification of ESP and managing the implementation of quality standards, processes, tools, and systems used in external service providers. Also responsible as a quality voice of Novartis to manage quality issues in day-to-day operations and ensure activities supported by third parties are in compliance with global regulations.

**Key responsibilities**:
Your responsibilities include, but are not limited to:

- Approval of external service provider Quality Risk Assessments (QRAs) to enable identification and evaluation of various metrics, risks, trends, and potential quality and performance issues with the ESP in a proactive manner.
- Responsible for adequate Quality Assurance Agreements (QAA) / quality terms with ESPs are in place.
- Responsible for approval / rejection of ESPs following qualification.
- Responsible for approval of subcontractors of ESPs.
- Responsible for review and approval of quality issues related to ESPs and ensure appropriate escalation of major and critical issues.
- Collaboration with Global Development Quality (GDQ), Vendor Partnerships & Governance (VPG), Global Medical Affairs (GMA) Enterprise Risk Management (ERM), other applicable Vendor Business Offices and Procurement to ensure their involvement in the risk evaluation and timely communication to the business and follow-up on required actions.
- Collaborate with VPG to review, tracking and trending issues related to ESP that are entered into the GDQ Risk Management Tool.
- Review quality metrics, monitoring and reporting including follow-up with line functions and escalation.

**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**

**Essential Requirements**:

- Minimum a bachelor’s degree in Life Sciences,

Pharmacy or Medicine, or other related discipline required
- 8+ years working experience in pharmaceutical development and excellent knowledge of the technical development and clinical operations processes and vendor related activities.
- Good knowledge of Good Clinical Practice (GCP)/ Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Vigilance Practice (GVP)
- Demonstrated leadership in implementing robust processes and quality systems, and setting global quality standards in a regulated area, including controlled documentation for the pharmaceutical development area.
- Experience in managing ESPs and knowledge of quality standards requirements.

**Desirable Requirements**:

- Demonstrated root cause analysis skills, Stakeholder engagement and critical thinking
- Excellent communication and interpersonal skills.

**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:

**You'll receive**:
**Commitment to Diversity & Inclusion**:
Novartis 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.

**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:
**Division**

Global Drug Development

**Business Unit**

QA GDD

**Work Location**

Holzkirchen (near Munich)

**Company/Legal Entity**

NBS GmbH

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Temporary

**Shift Work**

Yes

**Early Talent**

No

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