Associate Director, Risk Based Quality Management

hace 4 semanas

Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

**Associate Director, Risk based Quality Management**

**This is what you will do**:
Associate Director, Risk based Quality Management (AD RbQM) drives RbQM process in assigned studies or projects to ensure compliance with ICH-GCP R2, AZ SOPs and to safeguard clinical trial integrity and patient’s safety. AD RbQM works closely with Global Project and Study teams, SrS RbQM and CM Clinical Data Scientists at the initial stages of the studies to define critical to quality factors, quality tolerance limits and risk management strategies as well as coordinates and oversees work of SrSs RbQM and CM Data Scientists to define and execute Centralised monitoring support in eligible studies/projects. AD RbQM contributes to RbQM process and CM strategy by driving standardization and defining best practices

**You will be responsible for**:

- Leading RbQM process in eligible studies
- Demonstrating good understanding of a broader CM strategy and contributing to it by driving cross functional innovation/optimization projects
- Maintaining a high level of understanding of regulatory agencies and other external and internal stakeholders’ requirements in terms of data quality
- Engaging project teams, global and local study steams during initial stages of studies in order to develop study specific critical to quality factors, acceptable defect rates, quality tolerance limits and risk management strategies
- Developing, coaching, mentoring, motivating and inspiring individuals within the CM organization especially in the therapy area of interest
- Overseeing activities performed by Senior Specialist, RBQM
- Contributing to the development of CM methodology and CM best practices
- Expecting to coach more junior staff and supporting functional development through e.g. recruitment, training and mentoring
- Acting as SME on RbQM/CM in AZ optimization/best practices initiatives
- Collecting and reporting Adverse Events in accordance with AstraZeneca policies and procedures

**You will need to have**:

- Minimum of a BSc degree in Life Science
- Minimum of 4 years of experience in the Biotech/Pharma/CRO industry
- Deep understanding of the clinical development and risk based monitoring and Centralised monitoring methodologies
- Ability to define and lead improvement, innovation projects and interact with internal and external stakeholders at senior levels of management
- Excellent communication skills in both written and spoken English
- Strong Project Management and Risk Management skills
- Ability to mentor, train and lead teams in projects
- Agile responsiveness to industry and business needs and embracing peers’ review
- Demonstrates strong cross-functional leadership skills
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.

  • Associate Director, Development Asset Quality, Daq

    hace 5 días

    Barcelona, España AstraZeneca A tiempo completo

    **Associate Director, Development Asset Quality (DAQ)Location**: Barcelona This is what you will do: As part of the Development Quality Team you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for...

  • Associate Director, Quality Assurance

    hace 7 días

    Barcelona, España Pharmiweb A tiempo completo

    .Associate Director, Quality Assurance Barcelona, Catalonia Associate Director, Quality AssuranceBarcelonaBarcelona, Catalonia, ES We are Growing ! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning,...

  • Associate Director, Development Asset Quality, Daq

    hace 3 semanas

    Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

    Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...

  • Research & Development Quality Risk Management

    hace 4 semanas

    Barcelona, España Novartis A tiempo completo

    394206BR **Research & Development Quality Risk Management Manager**: Spain **About the role** **R&D Quality Risk Management Manager, Location: Barcelona, hybrid onsite, #LI-Hybrid.** As Research & Development Quality (RDQ) representative, you will support Regulatory Risk and Compliance by providing expertise and guidance to ensure that risk management...

  • Research & Development Quality Risk Management Manager

    hace 7 días

    Barcelona, España Novartis Farmacéutica A tiempo completo

    .Research & Development Quality Risk Management Manager Job ID 394206BRSpainSummary R&D Quality Risk Management Manager, Location: Barcelona, hybrid onsite, #LI-Hybrid.As Research & Development Quality (RDQ) representative, you will support Regulatory Risk and Compliance by providing expertise and guidance to ensure that risk management process and...

  • Research & Development Quality Risk Management

    hace 2 semanas

    Barcelona, Barcelona, España Novartis A tiempo completo

    394206BRResearch & Development Quality Risk Management Manager:SpainAbout the roleR&D Quality Risk Management Manager, Location: Barcelona, hybrid onsite, #LI-Hybrid.As Research & Development Quality (RDQ) representative, you will support Regulatory Risk and Compliance by providing expertise and guidance to ensure that risk management process and governance...

  • Head Risk Management

    hace 7 días

    Barcelona, España Novartis A tiempo completo

    .Summary :Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and...

  • Research & Development Quality Risk Management Manager

    hace 7 días

    Barcelona, España Healthcare Businesswomen’S Association A tiempo completo

    .Job Description SummaryR&D Quality Risk Management Manager, Location: Barcelona, hybrid onsite, #LI-Hybrid.As Research & Development Quality (RDQ) representative, you will support Regulatory Risk and Compliance by providing expertise and guidance to ensure that risk management process and governance is fit for purpose and meet Novartis standards and Health...

  • Research & Development Quality Risk Management

    hace 2 semanas

    Barcelona, España Novartis A tiempo completo

    **Summary**: **About the Role**: **Key Responsibilities**: - Supports RDQ risk management within RDQ, including management of the risk documentation, governance structure, and support meetings. - Provide guidance and expertise to QA and business partners on risk identification, root cause analysis, lifecycle management, and risk documentation to ensure...

  • Head Risk Management

    hace 7 días

    Barcelona, España Novartis A tiempo completo

    Summary : Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco - and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and...

  • Head Risk Management

    hace 3 semanas

    Barcelona, España Novartis A tiempo completo

    **Summary**: Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco - and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and...

  • Associate Director, Clinical Trial Management

    hace 4 semanas

    Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

    Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...

  • (Lmu303) | Head Risk Management

    hace 7 días

    Barcelona, España Es06 (Fcrs = Es006) Novartis Farmacéutica A tiempo completo

    .12 jun | ES06 (FCRS = ES006) Novartis Farmacéutica | BarcelonaDrive the strategy and adoption of robust risk management practices across the Vigilance System; oversee that teams are properly implementing the risk management cycle, quality issue management and methodologies and adhere to Novartis Corporate Standards.Establish and maintain the risk...

  • Associate Director, Clinical Trial Management

    hace 5 días

    Barcelona, España AstraZeneca A tiempo completo

    **Associate Director, Clinical Trial ManagementLocation**: Barcelona, Spain This is what you will do: The Associate Director (AD), Clinical Trial Management, supports the operational aspects of all clinical studies worldwide through providing resources, standard processes and direction for clinical trial execution through the direct linemanagement and...

  • Head Risk Management

    hace 7 días

    Barcelona, España Novartis Farmacéutica A tiempo completo

    .Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Head Risk Management

    hace 2 semanas

    Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

    Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and implementation of...

  • Associate Director, Clinical Trial Management

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Associate Director, Clinical Trial ManagementLocation: Barcelona, Spain This is what you will do: The Associate Director (AD), Clinical Trial Management, supports the operational aspects of all clinical studies worldwide through providing resources, standard processes and direction for clinical trial execution through the direct linemanagement and oversight...

  • Head Risk Management

    hace 2 semanas

    Barcelona, Barcelona, España Novartis A tiempo completo

    Summary:Responsible for establishing and maintaining the risk governance framework within PS&PV including identification & management of risks within the pharmaco- and medical devices vigilance system & PV Quality Management System (QMS) for Novartis group. It includes escalating risks to senior PS&PV leadership and overseeing the development and...

  • Associate Director Audit Quality Assurance

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    As the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients.The Associate Director Audit Quality Assurance is responsible for:Planning, leading, conducting and reporting...

  • (Lmu303) | Head Risk Management

    hace 7 días

    Barcelona, España Es06 (Fcrs = Es006) Novartis Farmacéutica A tiempo completo

    12 jun | ES06 (FCRS = ES006) Novartis Farmacéutica | Barcelona - Drive the strategy and adoption of robust risk management practices across the Vigilance System; oversee that teams are properly implementing the risk management cycle, quality issue management and methodologies and adhere to Novartis Corporate Standards. - Establish and maintain the risk...