Team Lead Quality
vor 2 Monaten
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
-
Team Lead Quality
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Novartis Vollzeit5600 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...
-
Product Quality Lead
vor 3 Wochen
Basel, Schweiz Swedish Orphan Biovitrum Vollzeit**Product Quality Lead** Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. The...
-
Product Quality Lead
vor 4 Wochen
Basel, Schweiz Sobi Vollzeit**Company Description** At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.** The Product Quality Lead provides...
-
Product Quality Lead
vor 4 Wochen
Basel, Schweiz Sobi VollzeitJob DescriptionThe Product Quality Lead provides cross-functional quality leadership and supports program deliverables for assigned products and associated on-going life-cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers across the network. The PQL is acting as main point...
-
Product Quality Lead
vor 3 Wochen
Basel, Schweiz Sobi VollzeitJob DescriptionThe Product Quality Lead provides cross-functional quality leadership and supports program deliverables for assigned products and associated on-going life-cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers across the network. The PQL is acting as main point...
-
Product Quality Lead
vor 3 Wochen
Basel, Schweiz Sobi, Inc VollzeitAt Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.Job DescriptionThe Product Quality Lead provides cross-functional...
-
Product Quality Lead
vor 3 Wochen
Basel, Schweiz Sobi, Inc VollzeitAt Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.Job DescriptionThe Product Quality Lead provides cross-functional...
-
Product Quality Lead
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Sobi VollzeitCompany Description At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.**The Product Quality Lead provides cross-functional...
-
Product Quality Lead
vor 2 Monaten
Basel, Schweiz Coopers Group AG VollzeitProduct Quality Lead For a fast-growing biotechnology firm that is focused on the development and production of innovative and life-changing products, we are seeking a highly skilled and motivated Product Quality Lead to join the team! As the Product Quality Lead, you will play a key role in ensuring the quality of our products from development to...
-
Product Quality Lead
vor 3 Wochen
Basel, Schweiz Coopers Group AG VollzeitProduct Quality Lead For a fast-growing biotechnology firm that is focused on the development and production of innovative and life-changing products, we are seeking a highly skilled and motivated Product Quality Lead to join the team! As the Product Quality Lead, you will play a key role in ensuring the quality of our products from development to...
-
Quality Engineering Lead
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Datalynx AG VollzeitZusammen mit Primetrack AG und Datalynx AG gehört die skillcloud AG zur Firmengruppe der Datalynx Group. Die skillcloud AG ist der Ansprechpartner bei Personalfragen sowie bei der Suche und Auswahl von Führungskräften und Spezialisten.**Hintergrund**:Wir suchen einen Quality Engineering Lead (m/w/d) mit Erfahrung in der Testautomatisierung, um neue...
-
Quality Control Lead Investigator
vor 3 Wochen
Basel, Schweiz Modis VollzeitFor a leader in the pharmaceutical industry, opportunity of minimum 15 months as Quality Control Lead Investigator. Your Role: - Act as Deviation Owner and Lead Investigator for QC deviations requiring a formal root cause analysis. - Enable and Support team of the Quality Control (QC) department responsible for testing raw materials, drug substance (API),...
-
Local Team Leader Quality Tool Manufacture
Vor 6 Tagen
Basel, Schweiz Ronal VollzeitLand/Region: CH- Ort: Härkingen- Funktionsbereich: Qualität- ID: 6399**HALLO!** Wir sind die RONAL GROUP. Unsere weltweit tätigen Mitarbeitenden sind unser wichtigstes Gut. Gemeinsam mit ihnen bewegen wir die Welt mit unserer Leidenschaft. **PASSEN WIR ZU DIR - UND DU ZU UNS?** Dürfen wir uns vorstellen: Die RONAL GROUP ist ein globales und...
-
Quality Control Lead Investigator
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Modis VollzeitFor a leader in the pharmaceutical industry, opportunity of minimum 15 months as Quality Control Lead Investigator.Your Role: Act as Deviation Owner and Lead Investigator for QC deviations requiring a formal root cause analysis. Enable and Support team of the Quality Control (QC) department responsible for testing raw materials, drug substance (API), drug...
-
Workshop Team Leader
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Jet Aviation AG VollzeitIn this position you are responsible for supporting the execution of Sheet Metal projects to achieve budget, safety, quality, and on-time delivery targets. Come on board and experience an environment that is dynamic, multicultural and inventive. The sky is the limit Your area of responsibility: Act as functional Team Lead of Sheet Metal Technicians on...
-
Workshop Team Leader
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Jet Aviation VollzeitThis position is responsible for supporting in the execution of workshop or aircraft cabin installation projects to achieve budget, safety, quality, and on-time delivery targets.Main Responsibilities: Functional Team Lead of Technicians and Certifying Workshop Technicians Able to lead a team of minimum 6 people Assigns, assists, and verifies upon completion....
-
Workshop Team Leader
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Hawker Pacific VollzeitSummary:Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft Management, Aircraft Sales, Charter, Completions, Defence, FBO, Fixed and Rotary Wing Maintenance, and Staffing. Behind every seamless Jet Aviation experience, is a team of...
-
Quality Engineering Lead
vor 3 Wochen
Basel, Schweiz Swisslinx VollzeitSwisslinx is collaborating with a prominent Swiss bank to fill a position for a Quality Engineering Lead who will be responsible for leading a team of internal and external test engineers. This position offers a combination of interesting responsibilities, a supportive team, convenient location, and flexibility, providing a favorable environment for your...
-
Director, Product Quality Lead
vor 3 Wochen
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: Reporting to the Sr Director, Global Quality Operations, the Director, Product Quality Lead will be responsible for providing quality oversight of drug products throughout the product and design control lifecycle. Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality and design control risks....
-
Workshop Team Leader
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Jet Aviation AG VollzeitThis position is responsible for supporting in the execution of Sheet Metal projects to achieve budget, safety, quality, and on-time delivery targets. Come on board and experience an environment that is dynamic, multicultural and inventive. The sky is the limit Your area of responsibility: Functional Team Lead of Technicians and Certifying Workshop...
