Team Lead Quality

vor 7 Monaten

Basel, Schweiz Novartis Vollzeit

5600 scientists working on 340 discovery programs in 8 disease areas focusing on 90 new molecular entities makes Novartis a premier place to develop your career as a pharmaceutical professional. If you are curious, scientifically minded, detail oriented and want to positively impact society by speeding the delivery of novel therapies to patients, then look no further, NIBR is the place to be.
As a Team Lead for our Quality & Compliance Excellence Group in Translational Medicine Pharmacokinetic Sciences, you will have the opportunity to make a difference. We are looking for professionals with expertise in Bioanalytics, pharmacokinetics, and familiarity with quality & information management systems. The role is within NIBR at the Novartis Global Headquarters in Basel, Switzerland. If you have a collaborative nature, a commitment to teamwork and a focus on continuous improvement, we want you to apply. As a Quality & Compliance Excellence Team Lead your responsibility will be to ensure the continuity of drug disposition science (with main focus on Bioanalytics) through compliance and process excellence with scope spanning late discovery to post-marketing. In this role you will resume leadership and supervision for two senior Quality & Compliance Excellence experts.
Your responsibilities will include but are not limited to:

- Accountable for leading global quality implementation and compliance activities within PK Sciences (PKS) including management of controlled processes, mandatory training, deviation reporting and quality metrics.
- Drive operational excellence and efficiency in the department through departmental document templates, process oversight, optimization, and training.
- Provide direction to various groups and functions in PKS to achieve a high level of compliance with established standards, best practices, and regulatory requirements.
- Support identification, overview, and prioritization of compliance improvement activities to enhance regulatory compliance within global Bioanalytics.
- Identify areas of concerns/deficiencies and propose improvement or training.
- Lead the CRO oversight, qualification and governance in compliance with the Novartis SOPs
- Collaborate with Quality Assurance and Bioanalytics Leadership Team to support preparation, conduct and follow up of audits and/or health authority inspections. Oversee preparation and completion of deviation reports and Corrective Action Plans, if any
- Be Line function Applicability representative for Standard Operating Procedures (SOP) assignment and coordinate SOP revision and other process documents.
- Maintain expertise in regulatory guidelines for ICH, FDA, and other Health Authorities (HA). Point of contact providing consolidated feedback to HA on behalf of Global BA.

**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:

- MS, PhD or equivalent in a relevant discipline
- Fluent English oral and written
- Significant experience relevant to this position in the pharmaceutical/CRO/related industry
- Strong scientific, process and operational background
- Fundamental understanding of bioanalytics and quality management systems and concepts
- Strong understanding of GLP and GCLP regulations

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
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 Novartis

**Division**

Novartis Institutes for BioMedical Research

**Business Unit**

Translational Medicine

**Country**

Switzerland

**Work Location**

Basel

**Company/Legal Entity**

Novartis Pharma AG

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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