Empleos actuales relacionados con Associate Director, External Service Provider Quality - Madrid - Advanced Accelerator Applications (Italy) - S...
-
Senior Quality Specialist External
hace 4 semanas
Madrid, Madrid, España Msd A tiempo completoJob SummaryOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. We are seeking a Senior Quality Specialist External to join our team in External Quality Assurance.Key ResponsibilitiesEvaluate and/or release products to other sites and/or to the market with the assurance that the goods were...
-
Associate Director, Quality
hace 3 semanas
Madrid, España Summittherapeutics A tiempo completoJob Title: Associate Director, Quality – EU Department: Quality Location: Remote Spain Overview of Role:The Associate Director, Quality-EU will support batch certification of IMP and commercial products for EU and Rest of the World. Responsible for QA oversight of manufacture and testing activities conducted at CMOs in Europe.Role and...
-
Associate Director External Manufacturing
hace 5 meses
Madrid, España Organon A tiempo completoFor our Global Packaging Technology External Manufacturing organization, we are looking for an: **Associate Director External Manufacturing Engineering - remote** This is a remote position and can be based in Amsterdam or Oss (The Netherlands), Heist-op-den-Berg (Belgium), Madrid (Spain), Cramlington (UK) or Dublin (Ireland) and requires an amount of travel...
-
Associate Director Of Client Quality
hace 4 semanas
Madrid, España Primevigilance A tiempo completo.Company DescriptionWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and...
-
Associate Project Manager
hace 1 mes
Madrid, Madrid, España Icon A tiempo completoJob Title: Associate Project ManagerWe are seeking a highly skilled and experienced Associate Project Manager to join our team at ICON. As a key member of our global study team, you will play a critical role in the delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management.Responsibilities:Leads/contributes to the...
-
Associate Project Manager
hace 1 mes
Madrid, Madrid, España Icon A tiempo completoJob Title: Associate Project ManagerWe are seeking a highly skilled and experienced Associate Project Manager to join our team at ICON. As a key member of our global study team, you will play a critical role in the delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management.Responsibilities:Leads/contributes to the...
-
Associate Director, Regulatory Affairs
hace 2 semanas
Madrid, España Cpl Healthcare A tiempo completo.Job Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Spain, Madrid – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due...
-
Senior Product Quality Manager
hace 5 meses
Madrid, España Organon A tiempo completo**Senior Product Quality Manager - External Quality Assurance** To be based in Amsterdam or Oss (The Netherlands) or Madrid (Spain) **Welcome to the team** The External Quality Packaging department consists of 25 people in charge of the oversight of the packaging sites around the world that act as CMOs to Organon. We are a very Dynamic and Diverse team...
-
Associate Director
hace 1 mes
Madrid, Madrid, España IQVIA A tiempo completo### Job Title: Associate Director ### Job Summary: We are seeking an experienced Associate Director to join our Patient-Centered Solutions (PCS) team at IQVIA. As an Associate Director, you will be responsible for managing and leading multiple consulting projects, ensuring on-time and on-budget delivery for clients in the pharmaceutical or related...
-
Associate Director
hace 1 mes
Madrid, Madrid, España IQVIA A tiempo completo### Job Title: Associate Director ### Job Summary: We are seeking an experienced Associate Director to join our Patient-Centered Solutions (PCS) team at IQVIA. As an Associate Director, you will be responsible for managing and leading multiple consulting projects, ensuring on-time and on-budget delivery for clients in the pharmaceutical or related...
-
Associate Project Manager
hace 4 semanas
Madrid, Madrid, España Pharmiweb A tiempo completoWe are seeking a highly skilled Associate Project Manager to join our team at Pharmiweb. The successful candidate will be responsible for leading and contributing to the preparation of delegated study documents, maintaining and facilitating interactions with internal and external functions, and ensuring efficient study delivery to time, costs, and quality...
-
Associate Project Manager
hace 4 semanas
Madrid, Madrid, España Icon A tiempo completoWe are seeking a highly skilled Associate Project Manager to join our team at ICON. The successful candidate will be responsible for leading and contributing to the preparation of delegated study documents, maintaining and facilitating interactions with internal and external functions, and ensuring efficient study delivery to time, costs, and quality...
-
Associate Director Of Client Quality
hace 4 semanas
Madrid, España Primevigilance A tiempo completoCompany DescriptionWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and...
-
Associate Project Manager
hace 4 semanas
Madrid, Madrid, España Pharmiweb A tiempo completoAssociate Project Manager Job DescriptionWe are seeking an experienced Associate Project Manager to join our global study team in BioPharmaceuticals Clinical Operations, Study Management. This is a permanent, fully home-based role that requires a strong background in clinical research and project management.Key Responsibilities:Lead and contribute to the...
-
Associate Project Manager
hace 4 semanas
Madrid, Madrid, España Pharmiweb A tiempo completoAssociate Project Manager Job DescriptionWe are seeking an experienced Associate Project Manager to join our global study team in BioPharmaceuticals Clinical Operations, Study Management. This is a permanent, fully home-based role that requires a strong background in clinical research and project management.Key Responsibilities:Lead and contribute to the...
-
Beca External Quality
hace 6 meses
Madrid, España Organon A tiempo completo**Job Requirements We are looking for an intern in our Madrid site for a period of 12 months (6 months + 6 months) to join us as soon as possible. **The department** External QA is set up to have quality oversight responsibility on external partners that manufacture and supply Active Pharmaceutical Ingredients, Formulated Drug Products to Organon. While...
-
Associate Director of Client Quality
hace 5 meses
Madrid, España PrimeVigilance A tiempo completo**Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
-
Intern External Quality
hace 5 meses
Madrid, España Organon A tiempo completo**Job Requirements **Who we are** Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it...
-
Associate Director, Regulatory Affairs
hace 4 semanas
Madrid, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market SurveillanceJob Type: Full Time, Permanent PositionLocations: Spain, Madrid – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology and Hepatology. Due to...
-
Associate Director, Regulatory Affairs
hace 2 semanas
Madrid, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Spain, Madrid – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...
Associate Director, External Service Provider Quality
hace 3 meses
Associate Director, External Service Provider Quality Job ID: REQ-10019461
Aug 16, 2024
Location: United Kingdom
Summary Primary Location: London Westworks, United Kingdom. Alternate Location(s): Dublin, Ireland / Barcelona, Spain / Madrid, Spain. Working model: All locations have a hybrid working model (12 days per month in the office). Note: Novartis is not able to offer relocation for this role. Please only apply if the location is accessible for you and you have the right to work in the country you are applying to.
About this role: As our Associate Director External Service Provider QA, you'll have the opportunity to oversee the implementation of quality standards, processes, and tools. You will manage external service providers across GxP areas in Global R&D Quality, ensuring that our partners meet the highest standards of excellence.
About the Role Major accountabilities:
Provide QA expertise and guidance to ensure compliance with quality system requirements, including implementation of quality risk-based and GxP-relevant processes. Review and approve External Service Providers (ESP) qualifications and ensure adequate Quality Assurance Agreements (QAA) are in place.
Lead quality oversight and collaborate with business partners and other quality groups to meet health authority and regulatory requirements. Translate functional QA strategy into operational activities and support risk-based implementation.
Review and approve external service provider Quality Risk Assessments (QRAs) to identify and evaluate risks, trends, and potential quality issues proactively.
Address quality and compliance gaps, implement strategic process improvements, and monitor the Quality Plan. Support inspection readiness activities and assist the Audit team with audit planning and completion of audit CAPA.
Support clinical trial teams in managing external service providers and IT systems for research and development activities, ensuring corrective and preventive measures for findings are developed and implemented.
Collaborate with business partners and Procurement for risk evaluation and timely communication of required actions. Review quality metrics and ensure follow-up with line functions.
Contribute to lessons learned from audits, inspections, and incidents, fostering a proactive, risk-based culture.
Role Requirements:
Experience:
12+ years of experience in pharmaceutical development with excellent knowledge of quality management systems and vendor management.
Education:
Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related discipline required.
Skills & Expertise:
Good knowledge of GCP/GLP, GMP, GVP.
Leadership in implementing robust processes and quality systems in a regulated area.
Experience managing External Service Providers and knowledge of quality standards and regulatory requirements.
Technical understanding of quality systems and clinical trial processes.
Experience in data analysis and trending.
Effective management of international and cross-divisional collaborations.
Root cause analysis skills and stakeholder engagement.
Why Novartis: Our purpose is to reimagine medicine to improve and extend lives. Join us in this mission
Commitment to Diversity and Inclusion: Novartis is committed to building an inclusive work environment and diverse teams.
#J-18808-Ljbffr
