Senior Quality Specialist

3 tygodni temu

REMOTE, Polska Parexel Pełny etat

Due to an expanding portfolio, we have an exciting opportunity for an experienced Senior Quality Specialist to be based in Eastern Europe, South Africa, or South America (Brazil). Candidates must have a strong clinical trial background, solid Quality knowledge, at least high-level awareness of statistical programming, and must be able to document this in their CV and demonstrate it in an interview.

Within the open position, the Senior Quality Specialists will act as a Quality partner for Biostatistics and Statistical Programming, focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients

Act as a Partner in Quality for Biostatistics and Statistical Programming staff members Perform risk-focused evaluations to ensure that the highest quality standards of Biostatistics and Statistical Programming work are met Facilitate identification, investigation and remediation of Quality Issues (QIs) related to Biostatistics and Statistical Programming activities Provide Quality input to audits/inspections Participate in or drive initiatives for further quality improvement of Biostatistics and Statistical Programming work Manage the relationship with Biostatistics and Statistical Programming local management
​Knowledge and Experience: Significant experience in one or more areas of Quality Management within clinical trial industry Knowledge of ICH-GCP and clinical trial regulation At least high-level knowledge of statistical programming and statistical analysis principles Experience in Quality Issue management and root cause methodologies (5-whys, fishbone diagram, etc.) Preferably audit and regulatory inspection support experience IT literate - experience with Microsoft Office applications and functional and TMF applications / languages / solutions. Able to embrace new technology and apply best practices English proficiency (written and oral)
Skills: Focused on quality results - attention to detail and First Time Quality Self-management: independent, takes initiative, proactive and organized Excellent interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback Emerging ability to lead without explicit authority Ability to develop professional, collaborative relationships both within Quality and with Operations (and clients where assigned) Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge Cultural awareness with the ability to think and work, globally Ability to travel as needed for the position
Education: Bachelor's Degree or other relevant experience required. Life-science, health or industry-related discipline preferred

#LI-REMOTE

  • Senior Quality Specialist

    1 miesiąc temu

    REMOTE, Polska Parexel Pełny etat

    Due to an expanding portfolio, there's an awesome chance for a skilled Senior Quality Specialist to work in Eastern Europe.Candidates need a solid programming knowledge to showcase in their CV and during the interview.At Parexel, Quality Specialists are key partners for GDO Biostatistics and Statistical Programming, focusing on top-notch quality, effective...

  • Quality Specialist

    5 dni temu

    REMOTE, Polska Parexel Pełny etat

    We are seeking a highly motivated and detail-oriented Quality Specialist (Regulatory Intelligence) to join our team. As a Quality Specialist, you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements relevant requirements. You will collaborate closely with stakeholders,...

  • Senior HR Operations Specialist

    1 miesiąc temu

    Remote, Polska Fortive Pełny etat

    We are seeking a highly organized and detail-oriented individual who is customer-obsessed to join our team as a Senior HR Operations Specialist. In this role, you will be responsible for providing support to employees and managing various data administration tasks through various channels and ensuring the delivery of exceptional HR services. Your primary...

  • Country Approval Specialist

    4 dni temu

    Remote, Polska Thermo Fisher Scientific Pełny etat

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

  • Senior Sales Manager

    3 tygodni temu

    Remote, Polska GE Pełny etat

    Job Description SummarySenior Sales Manager is a key role focused on driving growth by increasing sales of GEV's Onshore wind turbines in Eastern Europe. The successful candidate will be responsible for winning new business and managing projects and programs within the GE Vernova Onshore Wind team.Job DescriptionRoles and Responsibilities:Manage onshore wind...

  • Senior Sales Manager

    1 miesiąc temu

    Remote, Polska GE Pełny etat

    Job Description SummarySenior Sales Manager is a key role focused on driving growth by increasing sales of GEV's Onshore wind turbines in Eastern Europe. The successful candidate will be responsible for winning new business and managing projects and programs within the GE Vernova Onshore Wind team.Job DescriptionRoles and Responsibilities:Manage onshore wind...

  • Sr Feasibility Specialist

    3 tygodni temu

    Remote, Polska ThermoFisher Scientific Pełny etat

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to...

  • Sr Feasibility Specialist

    4 tygodni temu

    Remote, Polska ThermoFisher Scientific Pełny etat

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to...

  • Senior Data Engineer

    3 tygodni temu

    Remote, Poland (Remote) Vratislavia Software Pełny etat

    Vratislavia Software is looking for: Senior Data EngineerOur client is a leader in software, automotive, software development, cybersecurity and ALM solutions.As part of the cooperation, you will have the opportunity to take part in an international project for the medical industry. Your responsibilities:The data engineers are responsible for the data...

  • Principal Regulatory Affairs Consultant

    5 dni temu

    REMOTE, Polska Parexel Pełny etat

    Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines. The ideal candidate will possess strong regulatory affairs experience, project management skills, and...

  • Site Contract Associate

    1 miesiąc temu

    REMOTE, Polska Parexel Pełny etat

    Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep...

  • Senior Sales Manager

    1 miesiąc temu

    Remote, Polska GE Pełny etat

    Job Description SummaryJob Description SummarySenior Sales Manager is customer facing role, responsible for driving profitable growth through increasing sales of GEV’s world class Onshore wind turbines. Successful candidate will be responsible for winning business, impact approach, projects, and programs in Eastern Europe region as part of the GE Vernova...

  • Clinical Application Specialist Coronary IGT- Devices

    3 tygodni temu

    Poland - Remote Based Philips Pełny etat

    Job TitleClinical Application Specialist Coronary IGT- DevicesJob DescriptionClinical Application Specialist IGT-DevicesJoin the ever-expanding organization and an incredible team of dedicated experts and leaders in the Medical Device industry. Philips' Image Guided Therapy Devices (IGT-D), is a global leader in physiology and intravascular imaging for...

  • Clinical Application Specialist Coronary IGT- Devices

    1 miesiąc temu

    Poland - Remote Based Philips Pełny etat

    Job TitleClinical Application Specialist Coronary IGT- DevicesJob DescriptionClinical Application Specialist IGT-DevicesJoin the ever-expanding organization and an incredible team of dedicated experts and leaders in the Medical Device industry. Philips' Image Guided Therapy Devices (IGT-D), is a global leader in physiology and intravascular imaging for...

  • Clinical Application Specialist Coronary IGT- Devices

    1 miesiąc temu

    Poland - Remote Based Philips Pełny etat

    Job TitleClinical Application Specialist Coronary IGT- DevicesJob DescriptionClinical Application Specialist IGT-DevicesJoin the ever-expanding organization and an incredible team of dedicated experts and leaders in the Medical Device industry. Philips’ Image Guided Therapy Devices (IGT-D), is a global leader in physiology and intravascular imaging for...

  • Senior Angular developer part-time

    3 tygodni temu

    -, Poland (Remote) Glorium Technologies Pełny etat

    Project Description: We are seeking an experienced Senior Angular Developer to join our dynamic Healthcare project team. The ideal candidate should have a strong background in Angular development, with experience in an environment where Azure IoT and Terraform were used. As a Senior Angular Developer, you will be responsible for upgrading existing codebases,...

  • Senior Lead Full stack NET Developer with Angular

    3 tygodni temu

    Remote, Poland (Remote) EPAM Systems Pełny etat

    We are seeking a highly skilled and experienced Senior Software Engineer with expertise in .NET Full Stack for our client, a global consulting company. This position offers a fully remote model.RESPONSIBILITIESDevelop and maintain software applications using .NET technologiesWork with cross-functional team to design, develop, and deliver high-quality...

  • Clinical Research Associate

    2 tygodni temu

    Remote, Polska Thermo Fisher Scientific Pełny etat

    Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...

  • Senior Lead Full stack NET Developer with Angular

    3 dni temu

    Poland (Remote), PL EPAM Systems Pełny etat

    We are seeking a highly skilled and experienced Senior/Lead Software Engineer with expertise in .NET Full Stack for our client, a global consulting company. This position offers a fully remote model.RESPONSIBILITIESDevelop and maintain software applications using .NET technologiesWork with cross-functional team to design, develop, and deliver high-quality...

  • Senior Lead Full stack NET Developer with Angular

    7 dni temu

    Poland (Remote), PL EPAM Systems Pełny etat

    We are seeking a highly skilled and experienced Senior/Lead Software Engineer with expertise in .NET Full Stack for our client, a global consulting company. This position offers a fully remote model.RESPONSIBILITIESDevelop and maintain software applications using .NET technologiesWork with cross-functional team to design, develop, and deliver high-quality...