Quality Compliance Manager

4 semanas atrás

Lisboa, Lisboa, Portugal Amgen Sa Tempo inteiro

Join our team at AMGEN Capability Center Portugal, number 1 company in Best Workplaces - https://www.greatplacetowork.pt/ - ranking in Portugal (category 201-500 employees) by the Great Place to Work Institute.
We have a team of over 300 talented people and more than 35 different nationalities, diverse areas of expertise and professional experience that are shaping the future of healthcare.
This is your chance to explore a world of opportunities in different areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs and many more.
In Lisbon's city center, our AMGEN office fosters innovation, excellence, and inspiration.
Come thrive with us at AMGEN, supporting our mission To Serve Patients.
What we do at AMGEN matters in people's lives.
QUALITY COMPLIANCE MANAGER WHAT YOU WILL DO Let's do this
Let's change the world
In this vital role, you will report to the Sr Manager of Quality Compliance & Research Quality (CRQ).
As the Quality Compliance Manager, you will play a crucial part in our mission, providing proactive end-to-end quality support for developing and implementing a risk-based quality assurance strategy for the clinical development program.
The R&D Process Quality team supports the Quality Management System (QMS) across all Amgen research areas, including discovery through the clinical development lifecycle.
This team ensures that all Amgen's business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness.
The Process Quality team also ensures that Amgen's R&D Business Process Network develops and manages fit-for-purpose standards (SOPs) that are continuously improved upon using quality by design (QbD) and risk management methods, including QMS analytics showing quality signals and trends.
Responsibilities: Generate and review process area Knowledge Maps, determine inherent and residual risks, document risk assessments, and collaborate with Business Process Owners and Quality Leads to ensure accurate risk classification and preventive actions.Collaborate with GCP Subject Matter Expert, providing independent and objective quality advice supporting business procedures managed by Business Process Owners (BPOs).Provides Quality oversight related to continuous improvements (CI) associated with our QMS through metrics and key performance indicators (KPIs).Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to enable Management Reviews (periodic review by management to ensure QMS health is maintained).Ensures our CI efforts maintain a quality culture throughout the R & D and GDO organizations.Supports Amgen's procedural framework so that all procedures maintain compliance with relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity.Supports the Business Process Owner network by ensuring risk-based improvements to procedures to ensure that they are simple, efficient, and fit for purpose while maintaining regulatory compliance.Supports risk methodologies to selectively audit business processes across the R&D network that will ensure improvements to procedures through robust root cause analysis and CAPA aimed at improving procedures.Identify industry best practices for optimal (standardized and lean) procedural documentation and the use of technology to drive an efficient and effective knowledge management system.Contributes and supports R & D with the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/ Corrective and Preventative Actions (CAPA).Supports a robust regulatory intelligence system by monitoring changing regulations and ensuring that the BPO network incorporates changes efficiently and timely.WHAT WE EXPECT OF YOU We are different, yet we all use our unique contributions to serve patients.
The individual we seek has technological literacy and leadership skills and has these qualifications.
Basic Qualifications: Master's degree and 2 years of Quality/Compliance/Process Management experience ORBachelor's degree and 4 years of Quality/Compliance/Process Management experience ORAssociate's degree and 8 years of Quality/Compliance/Process Management experience ORHigh school diploma / GED and 10 years of Quality/Compliance/Process Management experience.Preferred Qualifications: 7 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes).Solid understanding of SOP/Standards management and methods/ technology used to drive knowledge management across a diverse R&D environment.Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMSs such as Veeva or Trackwise.Thorough understanding of Clinical R&D activities and Global Regulations.Experience with Regulatory Submission and Inspection Management procedures.Strong analytical, critical thinking, and decision-making abilities.Strong Process Mind and analytically oriented - experience with process monitoring, including applying analytical methods and modern technology to enable signal detection and quality improvement.Proven team player – takes direction and can rapidly learn and support a hard-working team, making rapid decisions and communicating them promptly.Excellent verbal and written communication skills - demonstrates strong business writing abilities and active listening.Capability to understand and articulate technical concepts and literature in spoken and written English.WHAT YOU CAN EXPECT OF US Vast opportunities to learn, develop, and move up and across our global organization.A diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.Flexible work arrangements.APPLY NOW Objects in your future are closer than they appear.
Join us. CAREERS.AMGEN.COM EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.
Please contact us to request an accommodation.

#J-18808-Ljbffr

  • Quality Compliance Manager

    4 semanas atrás

    Lisboa, Lisboa, Portugal Amgen Sa Tempo inteiro

    .Join our team at AMGEN Capability Center Portugal, number 1 company in Best Workplaces - https://www.Greatplacetowork.Pt/ - ranking in Portugal (category 201-500 employees) by the Great Place to Work Institute.We have a team of over 300 talented people and more than 35 different nationalities, diverse areas of expertise and professional experience that are...

  • Compliance Renewal Manager

    Há 6 dias

    Lisboa, Lisboa, Portugal Sovos Compliance Tempo inteiro

    Job SummaryWe are seeking a highly skilled and experienced Compliance Renewal Manager to join our newly created Renewals organization. As a key member of our team, you will be responsible for cultivating relationships with key stakeholders within our customers, collaborating with Account Management and Customer Success to build comprehensive account plans,...

  • Quality and Compliance Specialist

    Há 2 dias

    Lisboa, Lisboa, Portugal Mantell Associates Tempo inteiro

    We are partnering with an innovative biopharmaceutical company to find a highly skilled Contract Quality Control Manager to join their team.Key Responsibilities:The successful candidate will oversee the sampling process to ensure quality, including the production of samples and interpretation of blueprints.They will conduct analyses of various materials and...

  • Compliance Product Manager

    Há 4 dias

    Lisboa, Lisboa, Portugal Shield Financial Compliance Tempo inteiro

    Job SummaryAs a Product Owner at Shield Financial Compliance, you'll take ownership of defining and delivering features that address customer needs and meet business objectives. You'll work closely with stakeholders, R&D, and design teams to ensure smooth and successful delivery of innovative and impactful product features.Key Responsibilities:Own the...

  • Cloud Systems Manager

    1 dia atrás

    Lisboa, Lisboa, Portugal Shield Financial Compliance Tempo inteiro

    About Shield Financial ComplianceAs a global startup, we value innovation, quality, and excellence. We strive to provide an exciting and fun work environment for our employees, fostering collaboration and growth within our teams. With offices in various locations, we offer opportunities for talented professionals to join our company and contribute to our...

  • Aml Compliance Manager Compliance

    3 semanas atrás

    Lisboa, Lisboa, Portugal Lumonpay Tempo inteiro

    .About Us:At Lumon, we're passionate about protecting our customers and maintaining the highest standards of compliance.We're seeking a dynamic and experienced AML Compliance Manager to join our Risk & Compliance team in Lisbon.Reporting to the European Compliance Manager and MLRO in Dublin, you will play a crucial role in safeguarding Lumon's operations and...

  • Quality Assurance Manager

    Há 4 dias

    Lisboa, Lisboa, Portugal Phiture Tempo inteiro

    Join Our TeamWe are seeking an experienced Quality Assurance Manager to lead our Quality Assurance team. The successful candidate will have a strong background in quality assurance, experience with call center operations, and excellent leadership skills.Responsibilities:Develop and implement quality assurance frameworks to ensure compliance with regulatory...

  • Compliance Manager

    Há 18 horas

    Lisboa, Lisboa, Portugal GLO Comms Tempo inteiro

    Glocomms seeks a seasoned Compliance Manager to oversee our compliance program. As a key member of our team, you will be responsible for ensuring that we remain compliant with relevant laws and regulations.This includes developing and implementing compliance policies, conducting audits, and providing training to employees on compliance best practices.Main...

  • Aml Compliance Manager Compliance

    2 semanas atrás

    Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiro

    LisboaEUR 30000 - 40000About Us:At Lumon, we're passionate about protecting our customers and maintaining the highest standards of compliance. We're seeking a dynamic and experienced AML Compliance Manager to join our Risk & Compliance team in Lisbon. Reporting to the European Compliance Manager and MLRO in Dublin, you will play a crucial role in...

  • Manager Quality Systems

    1 semana atrás

    Lisboa, Lisboa, Portugal Helm Ag Tempo inteiro

    .Experience HELM as a unique family business and an attractive employer.Through a constant exchange of ideas, our ultimate goal is to offer our customers future-oriented solutions within our global network.At any time, in any place.This allows us to work proactively and think long-term - in operations, quality management, process optimization, product...

  • Quality Control and Compliance Specialist

    Há 6 dias

    Lisboa, Lisboa, Portugal Mantell Associates Tempo inteiro

    As a Contract Quality Control Manager with Mantell Associates, you will be responsible for ensuring the quality of products manufactured by our partner company. This involves overseeing the collection and production of samples, interpreting blueprints, and conducting analyses.We are looking for a highly skilled professional with a Bachelor's degree in...

  • Regulatory Compliance Manager

    4 semanas atrás

    Lisboa, Lisboa, Portugal Revolut Tempo inteiro

    Regulatory Compliance Manager (Quality Control) - PortugalPeople deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products — including spending, saving, investing, exchanging, travelling, and more — help our 50+ million customers get more from...

  • Aml Compliance Manager Compliance

    2 semanas atrás

    Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiro

    LisboaEUR 30000 - 40000About Us:At Lumon, we're passionate about protecting our customers and maintaining the highest standards of compliance. We're seeking a dynamic and experienced AML Compliance Manager to join our Risk & Compliance team in Lisbon. Reporting to the European Compliance Manager and MLRO in Dublin, you will play a crucial role in...

  • Compliance and Quality Assurance Director

    1 dia atrás

    Lisboa, Lisboa, Portugal TN Portugal Tempo inteiro

    Fusion seeks a seasoned validation manager to lead and oversee validation activities across various project settings, including SAP implementation, upgrade or enhancement, and transformational projects.This role will cover qualification activities, computer system validation, process validation, and ensuring compliance with regulatory standards throughout...

  • Digital Quality Manager

    Há 4 dias

    Lisboa, Lisboa, Portugal GrabJobs Tempo inteiro

    GrabJobs is seeking a skilled Digital Quality Manager to lead our quality management initiatives. In this role, you will be responsible for collaborating with our Chief Marketing Officer on designing and documenting procedures, ensuring compliance with ISO 9001:2015 requirements, and monitoring quality service management procedures.The ideal candidate will...

  • Compliance and Risk Manager

    1 dia atrás

    Lisboa, Lisboa, Portugal Phiture Tempo inteiro

    Ferring Pharmaceuticals is a leading company in the field of reproductive and women's health, gastroenterology, and urology. We are currently seeking a Compliance and Risk Manager to join our team.The successful candidate will have 8-10 years of experience in IT compliance or quality management within a pharmaceutical or highly regulated environment. A...

  • Manager Quality Systems

    1 semana atrás

    Lisboa, Lisboa, Portugal Helm Ag Tempo inteiro

    .Experience HELM as a unique family business and an attractive employer.Through a constant exchange of ideas, our ultimate goal is to offer our customers future-oriented solutions within our global network.At any time, in any place.This allows us to work proactively and think long-term - in operations, quality management, process optimization, product...

  • Senior Quality Control Manager

    Há 4 dias

    Lisboa, Lisboa, Portugal Descompagnons Trabalho Temporário Lda Tempo inteiro

    Descompagnons Trabalho Temporário Lda Seeks a Quality Control ManagerWe are looking for a qualified individual to join our team as a Contract Quality Control Manager.Job Description:The selected candidate will be responsible for overseeing the quality control process, including sample collection and production, blueprint interpretation, and analysis of...

  • Project Quality Manager

    Há 7 dias

    Lisboa, Lisboa, Portugal Hito Solutions Tempo inteiro

    Our client is a company that is expanding greatly in the energy market and is one of the largest methanol producers in the world.They work on EPC projects in various parts of the world.Responsibilities: Assist the QSE Director in achieving the department's established objectives.Provide quality assurance support to various company departments, with a...

  • Procurement and Compliance Manager

    Há 4 dias

    Lisboa, Lisboa, Portugal Nexxiot Tempo inteiro

    Nexxiot is seeking a Procurement and Compliance Manager to join our team. As a key member of our supply chain team, you will be responsible for ensuring the highest level of quality in our supplier partnerships.About UsNexxiot is a pioneering digital freight asset management company that connects the world's most extensive network of intermodal containers...