Quality Manager
vor 18 Stunden
500+ People are dedicated to maintaining the highest standards for Quality across GDD.
- In Technical Research & Development Quality Assurance, we strongly collaborate with our business partner to ensure that the TRD portfolio is delivered on time and with excellent quality and provide QA oversight and guidance to the local TRD facilities. We support innovation and product development throughout all clinical phases including transfer to the NTO organization and maintain the highest GMP standards to deliver novel therapies to our patients by ensuring their safety.
- The Quality Manager will provide quality assurance expertise, guidance, and support to various operational activities in Technical Research & Development (TRD) to ensure compliance with applicable regulatory requirements, Novartis procedures and quality standards.
- Your key responsibilities:
- Your responsibilities include, but are not limited to:
- Member of the TRD project teams and TRD sub-teams, representing QA for the assigned portfolio
- Release of Drug Substance and Drug Product batches, Intermediates and materials for world-wide clinical trials and issuance of corresponding batch certificates, under delegation of the Swiss FvP.
- Deviation and Change Control management for assigned portfolio
- Oversight on the review of master and executed batch records performed by the QA specialists, including clarification of all deficiencies in GMP documents, and supervision of agreed follow-up
- Write, review and complete GMP-relevant documents.
- QA Approver of GMP documentation owned by TRD according to internal procedures
- Support audits and inspections in case of questions on assigned portfolio
- Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management
- QA point of contact for assigned Contract Manufacturing Organisation (CMO) partners, support on-site visits and audit preparations at CMO, follows up audit CAPAs, and supports review of CMO KPIs and input to Quality agreements
- Support QA walkthroughs in various TRD facilities.
**Commitment to Diversity & Inclusion**:
- Novartis is 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:
- Essential:
- Bachelor’s degree with 5+ years’ experience or Master’s Degree with 3+ years’ experience in pharma Quality Assurance and operational areas.
- Good knowledge of cGMP, working knowledge in technical development or commercial manufacturing, production or analytics.
- Sound scientific, technical and regulatory knowledge.
- Strong organizational and decision-making skills, ability to work independently with little to no supervision.
- Strong and shown ability to analyse and evaluate cGMP compliance and product safety. Able to navigate in a regulated environment with the flexibility given to the development phase
Why Novartis?
- 766 million lives were touched by Novartis medicines in 2020, 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**
- Global Drug Development
**Business Unit**
- QA GDD
**Country**
- Switzerland
**Work Location**
- Basel
**Company/Legal Entity**
- Novartis Pharma AG
**Functional Area**
- Quality
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
-
Quality Manager
vor 7 Monaten
Basel, Schweiz Panda VollzeitQuality manager Job description **Quality Manager (f/m/d) 100%** A leading contract development and manufacturing partner (CDMO) for biotech and pharma customers is seeking a Quality Manager. The role involves commissioning, qualification, and process validation of a new manufacturing facility, as well as establishing the quality management system and...
-
Quality Assurance Manager
vor 7 Monaten
Basel, Schweiz Panda Vollzeit**Quality Manager (f/m/d) 100%** A leading contract development and manufacturing partner (CDMO) for biotech and pharma customers is seeking a Quality Manager. The role involves commissioning, qualification, and process validation of a new manufacturing facility, as well as establishing the quality management system and processes to ensure compliance with...
-
Global Quality Manager Distribution Quality
vor 7 Monaten
Basel, Schweiz Work Selection Vollzeit**Beschreibung**: For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated **Global Quality Manager Distribution Quality** for a temporary contract of 12 months with a possible extension. **Tasks**: - Manage GDP non-conformities or logistics related events (e.g. Temperature Monitoring issue,...
-
Global Quality Manager Distribution Quality
vor 7 Monaten
Basel, Schweiz GITR Vollzeit**INTRODUCTION**: As a preferred supplier for Roche Basel, we are looking for an individual as **Global Quality Manager Distribution Quality**: - (contract for 12 Months, with possible extension). The start date is asap or within 2 months. Remote/Home Office: on-site required 3 of 5 days a week. **ASSIGNMENT DESCRIPTION**: - Manage GDP non-conformities...
-
Quality Assurance Manager
vor 2 Monaten
Basel, Schweiz ITech Consult Vollzeit**Project**: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified **Quality Assurance Manager (M/F/d).** **Background**: As part of the Quality Unit on-site, the team QA Facility & Engineering ensures GMP compliance of all production facilities at the Basel Drug Substance Manufacturing site. The team’s...
-
Quality Assurance Manager
Vor 3 Tagen
Basel, Schweiz Global Kader Personal Vollzeit**EINFÜHRUNG**: Als Preferred Supplier für Roche Basel in suchen wir eine engagierte Persönlichkeit als **Quality Assurance Manager**: (Vertragstyp 3 Monate mit Möglichkeit auf Verlängerung) mit Startdatum so rasch wie möglich oder innerhalb von zwei Monaten. Remote/Home Office: hybrid, gemäss gesetzlichen Vorgaben, on site wird...
-
Imp Quality Manager
vor 19 Stunden
Basel, Schweiz ITech Consult Vollzeit**IMP Quality Manager (m/w/d) - Quality / Compliance / GMP / English / Deutsch** **Projekt**: Für unseren Kunden in Basel suchen wir einen hochqualifizierten IMP Quality Manager **Hintergrund**: Die IMP (investigation medicinal product) Quality Organisation Schweiz ist der Quality Partner für alle Produktionseinheiten (Drug Substance und Drug Product)...
-
Quality Assurance Manager
vor 7 Monaten
Basel, Schweiz Batterman Consulting Basel AG Vollzeit**Unser Kunde** Unser Kunde ist eine führende und anerkannte Dienstleisterin in der chemisch-pharmazeutischen Industrie mit rund 100 Mitarbeitenden. Das inhabergeführte Unternehmen, hat sich auf die Entwicklung und Produktion von Wirkstoffen und Endprodukten spezialisiert und produziert und verpackt mit einem modernen Maschinenpark vorwiegend Tabletten...
-
Quality Assurance Manager
vor 7 Monaten
Basel, Schweiz Flex VollzeitFlex, a Fortune global 500 company, is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that...
-
Manager Quality
vor 2 Monaten
Basel, Schweiz VECTURA FERTIN PHARMA VollzeitContract Type: Permanent Closing date: Reference: VN1911 - Who we are Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery...
-
Quality Assurance Manager
vor 12 Stunden
Basel, Schweiz Actalent VollzeitOur client is seeking an experienced Technical QA Manager to join their IMP Quality Operations Unit in Basel. This team plays a critical role in ensuring GMP compliance and quality oversight for Investigational Medicinal Products (IMPs) manufactured and packed in Switzerland. The ideal candidate will bring extensive expertise in qualification and validation...
-
Analytical Quality Assurance Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitAbout the RoleWe are seeking a highly skilled Analytical Quality Assurance Manager to join our team at Gi Group SA. As a key member of our organization, you will be responsible for ensuring the highest standards of quality in our analytical-pharmaceutical environment.Key Responsibilities:Review and approve SOPs, protocols, reports, Certificate of Analysis,...
-
Quality Assurance Manager
Vor 2 Tagen
Basel, Schweiz Hengrui USA Vollzeit**Reports to (Title): Global Head of Quality Assurance & Training** **Location: Europe or US** **Exempt/Non-Exempt: Exempt** **Direct Reports : No** **Department: Quality Assurance & Training** The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative medicines portfolio for the US, Europe and Japan. Our...
-
Quality Manager, Commercial Quality Europe
vor 7 Monaten
Basel, Schweiz BeiGene VollzeitGeneral Description: The incumbent will report to the Head Commercial Quality Europe and will be responsible for supporting activities relating to BeiGene’s external GMP operations in Europe and as well as internal BeiGene GMP processes, ensuring procedures and systems are in place to support BeiGene’s commercial products. The incumbent will support...
-
Quality Manager, Imp Quality Europe
Vor 7 Tagen
Basel, Schweiz BeiGene VollzeitGeneral Description:_ The position will report to the Director IMP Quality Europe and located in Basel, Switzerland. Core responsibilities to support day-to-day Quality operational activities supporting clinical studies in the EU region. Key responsibilities are assessment of product temperature excursions and review of clinical batch records ready for...
-
Imp Quality Manager
vor 2 Wochen
Basel, Schweiz Coopers Group AG VollzeitIMP Quality Manager For our Pharma client we are looking for a IMP Quality Manager Tasks & Responsibilities: The role of IMP QA Manager is assigned as a delegate of the Swiss Responsible Person for IMPs in Basel and: - Responsible for the lot disposition of IMP e.g. bulk drug product materials and active pharmaceutical ingredients (API) - Ensures that the...
-
Global Quality Manager
vor 2 Monaten
Basel, Schweiz F. Hoffmann-La Roche Gruppe VollzeitRoche fosters diversity, equity, and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Quality Assurance Manager
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitAbout the JobWe are seeking a highly skilled Quality Assurance Manager to join our team at Gi Group SA. As a Quality Assurance Manager, you will be responsible for ensuring that all aspects of quality management meet regulatory requirements and industry standards.Key Responsibilities:Implement and maintain quality systems and processes in accordance with...
-
Quality Assurance Manager
Vor 4 Tagen
Basel, Schweiz Work Selection Vollzeit**Beschreibung**: Für unseren Kunden, ein weltweit führendes Schweizer Pharmaunternehmen in Basel, suchen wir per sofort einen **Quality Assurance Manager** für einen befristeten Einsatz von 12 Monaten mit Option auf Verlängerung. Als Quality Assurance Manager im Chapter QA Facility & Engineering stellt man die Einhaltung und ständige Verbesserung der...
-
Manager, External Quality Control
vor 7 Monaten
Basel, Schweiz Moderna Therapeutics Vollzeit**To be considered for this role, you must supply a CV / resume in English (as English is our internal business language) Additionally, this role will be working closely with our CMO partners who have locations in Europe (Italy) - therefore, trips to the sites are expected to be frequent (as we have a face-to-face / on-site ethos)** **The Role**: Reporting...
