Senior Project Quality and Risk Lead

1 tydzień temu

Kraków, Lesser Poland Parexel Pełny etat

When our values align, there's no limit to what we can achieve.

We are currently looking for experienced Project Quality and Risk Lead​s with expertise with ICH-GxP principles and clinical trial regulations to be based in Romania or Poland or Lithuania or Hungary or Spain or Turkey .

As the Senior Project Quality and Risk Lead you will actively act as Risk Manager, being responsible to coordinate Critical to Quality (CtQ) identification, risk identification, evaluation, and controls.

This position can also be part of a global project management team.
Senior Project Quality and Risk Lead assigned to projects and/or accounts will collaborate closely with the broader PQRM groups and other quality teams.

The PQLC model delivers the services of PQRLs who provide expert quality advice to the project team regarding potential risks and the oversight of the risks through-out the lifecycle of the clinical trial.
Partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise to support operations, leadership, and clients, enabling the safeguarding and maintenance of patient safety, data integrity and regulatory compliance.

Skills:

Very good interpersonal, verbal, and written communication skills including effective listening, facilitating group discussions, influencing without authority, and providing appropriate feedback.

Superior analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming, and imagining alternatives and assessing the effectiveness of actions.

High ability to develop professional, collaborative relationships both internally and with the client.

Very good skills 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.

Ability to plan, organize, prioritize, and manage workload independently, keeping the patient and client at the focus.

Highly quality oriented with an attention to detail, taking initiative, ownership, and accountability for deliverables.

Advanced ability to manage the complexity of a matrix environment while valuing the importance of teamwork.

Ability to travel 10% - 15%.

Knowledge and Experience:

Advanced level experience and understanding in any area or combination of either Phase II-III or Late Phase /IV clinical project management and demonstrable experience in Quality or Risk Management activities are essential.

Expertise with ICH-GCP principles

Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA development

Previous CRO experience is strongly preferred (applications from candidates with pharma experience will also be considered)

English proficiency (written and oral)

Education:

Bachelor's Degree or other relevant experience required. Life-science or other health-related discipline preferred.

Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you'll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology "super user" or collaborator are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees.

  • Senior Director – Commercial Risk Service Delivery Lead

    1 tydzień temu

    Kraków, Lesser Poland Aon Pełny etat

    Senior Director - Commercial Risk Service Delivery Lead Do you have Risk operations expertise? Are you ready for your next career move at Aon? This newly created role will be based in the Krakow, Poland service center, and will call on your Aon network and operations leadership experience across EMEA to create a cohesive service solution for...

  • Risk Project Manager

    1 tydzień temu

    Kraków, Lesser Poland Aon Pełny etat

    Project Manager Are you a driven, organized, goals focused project manager with proven success in managing multiple stake holders? This could be your next career step built within the world's leading insurance broking firm. We are seeking interested candidates for the role of "Project Manager" within the APAC Risk function but with location in Poland...

  • Risk Project Manager

    1 tydzień temu

    Kraków, Lesser Poland Aon Hewitt Pełny etat

    Project ManagerAre you a driven, organized, goals focused project manager with proven success in managing multiple stake holders?This could be your next career step built within the world's leading insurance broking firm.We are seeking interested candidates for the role of "Project Manager" within the APAC Risk function but with location in Poland given the...

  • Senior Analyst, Risk Governance

    1 tydzień temu

    Kraków, Lesser Poland HSBC Service Delivery Pełny etat

    Senior Analyst, Risk Governance Kraków, Lesser Poland Voivodeship Some careers shine brighter than others.If you're looking for a career that will help you stand out, join HSBC, and fulfil your potential. Whether you want a career that could take you to the top, or simply take you in an exciting new direction, HSBC offers opportunities, support and rewards...

  • Senior Business Analyst with Risk

    1 tydzień temu

    Kraków, Lesser Poland Nexus Jobs Limited Pełny etat

    Job DescriptionSenior Business Analyst With RiskOur Client - an international Bank is looking to recruit a Senior Business Analyst with at least 5 to 7 years experience as Business Analyst.The team has a responsibility to deliver to a set of expected standards being set by the Regulatory Reporting Assurance programme, and delivers to a standard playbook...

  • Specialist Technology Risk Lead

    1 tydzień temu

    Kraków, Lesser Poland Nexus Jobs Limited Pełny etat

    Job DescriptionGlobal Resilience Risk SpecialistTechnology Risk LeadGlobal Operational and Resilience Risk (ORR) is a sub function of Group Risk. Its purpose is to make sure the bank understands, and is in control of its non-financial risk position.In addition, the function provides resilience risk stewardship to global businesses, functions and entities we...

  • Control Design and Oversight Senior Lead

    1 tydzień temu

    Kraków, Lesser Poland ITDS Business Consultants Pełny etat

    Control Design and Oversight Senior LeadJoin us, and manage impactful cybersecurity policies and proceduresKrakow-based opportunity with the possibility to work 100% remotelyAs a Cybersecurity Control Design and Oversight Lead, you will be working for our client, a global financial institution. This role is crucial in designing and maintaining the...

  • Control Design and Oversight Senior Lead

    1 tydzień temu

    Kraków, Lesser Poland ITDS Business Consultants Pełny etat

    Control Design and Oversight Senior LeadJoin us, and manage impactful cybersecurity policies and proceduresKrakow-based opportunity with the possibility to work 100% remotelyAs a Cybersecurity Control Design and Oversight Lead, you will be working for our client, a global financial institution. This role is crucial in designing and maintaining the...

  • AVP, Model Risk Management

    1 tydzień temu

    Kraków, Lesser Poland dotCommunity Sp z o. o. Pełny etat

    Company:Joinone of the world's largest banking and financial services organisations Our Client's global businesses serve more than 40 million customers worldwide through a network that covers 64 countries and territories..Overview:Model Risk Management (MRM) at our client's company is structured as a global function, headed up by the Chief Model Risk Officer...

  • Risk and Compliance Analyst

    1 tydzień temu

    Kraków, Lesser Poland PerkinElmer Pełny etat

    PerkinElmer is searching for a Risk and Compliance Analyst to join our risk and compliance program. As part of the CISO function, directly reporting to the Head of Risk and Compliance, the Risk and Compliance Analyst will support the design and operation of our compliance program supporting a 1B+ in revenue global manufacturing and services business. The...

  • Senior Project Manager

    1 tydzień temu

    Kraków, Lesser Poland HBK Engineering, LLC Pełny etat

    HBK Engineering, LLC Senior Project Manager San Antonio , Texas Apply Now HBK Engineering is seeking a Senior Project Manager. This position offers the opportunity to be part of a project team consisting of professional engineers, project engineers and designers who are involved in the design, modification, and analysis of new and existing utility systems. A...

  • Vice President, Model Validation, Governance And Risk Stewardship

    1 tydzień temu

    Kraków, Lesser Poland HSBC Service Delivery Pełny etat

    Technologies-expected : Python about-project : Selected candidate will lead validations of the Credit Risk Models used for Regulatory Reporting Purposes (i.e., quantitative analysis and qualitative research with focus on model data, design, performance, and implementation) to formulate opinions about models' conceptual soundness and adequacy for intended...

  • Risk Analyst

    1 tydzień temu

    Kraków, Lesser Poland Hitachi Vantara Corporation Pełny etat

    Description As a Risk Analyst, you will be responsible for supporting a Hitachi Energy Enterprise Risk Manager inmanaging cross-organizational risk themes through-out its life cycle, coordinating with other risk functionsand improving organizational resilience. This position reports to the Hitachi Energy Enterprise Risk Manager.Your responsibilities:...

  • Senior/Lead Auditor

    3 tygodni temu

    Kraków, Lesser Poland Philip Morris International Pełny etat

    *the final job title (Lead or Senior Auditor) depends on candidate's skills and background.MAKE HISTORY WITH USAt PMI, we've chosen to do something incredible. We're totally transforming our business and building our future on smoke-free products with the power to deliver smoke free future. With huge change, comes huge opportunity. When you join us, you'll...

  • Senior/Lead Auditor

    1 miesiąc temu

    Kraków, Lesser Poland Philip Morris International Pełny etat

    *the final job title (Lead or Senior Auditor) depends on candidate's skills and background.MAKE HISTORY WITH USAt PMI, we've chosen to do something incredible. We're totally transforming our business and building our future on smoke-free products with the power to deliver smoke free future. With huge change, comes huge opportunity. When you join us, you'll...

  • Senior Operations Lead, Cash and AR Management

    1 tydzień temu

    Kraków, Lesser Poland Google Inc. Pełny etat

    Senior Operations Lead, Cash and AR Management Apply Bachelor's degree in Business, Finance, Engineering, Operations or equivalent practical experience. 7 years of experience in operations with a focus on measurable results and continuous process improvement techniques.Experience in a customer-facing team/role, balancing operational results with customer...

  • AVP, Model Risk Management

    1 tydzień temu

    Kraków, Lesser Poland Belvedere Recruitment Pełny etat

    AVP, Model Risk Management Belvedere Recruitment Kraków, Poland Posted 11 days ago Hybrid Job Permanent Competitive Only apply if you have a work permit or a right to work in Poland. Leadership opportunity in a globally recognised finance corporationCrucial role in Model Risk Management (MRM) ensuring rigorous validation processes.Competitive salary with...

  • Senior Technology Consultant

    1 tydzień temu

    Kraków, Lesser Poland Smartchoice International Pełny etat

    Senior Recruitment Consultant - Permanent & Contracting Roles │ Fast & High-Quality Headhunting ServicesJob Title : Senior Sharepoint ConsultantJob Location : Krakow, PolandJob Type: B2B ContractResponsibilities:Interface with clients to understand requirements, provide quality assurance, and resolve issues promptly to ensure high customer...

  • Business and Project Management Specialist

    1 tydzień temu

    Kraków, Lesser Poland ITDS Business Consultants Pełny etat

    Business and Project Management SpecialistJoin us, and make an impact on global cybersecurity strategyKrakow-based opportunity with the possibility to work 95% remotelyAs a Business and Project Management Specialist, you will be working for our client, a global leader in cybersecurity, safeguarding customers and colleagues from cyber threats while...

  • Vp, Model Risk Management

    1 tydzień temu

    Kraków, Lesser Poland Hsbc Service Delivery Pełny etat

    Technologies-expected : Python R Matlab C++ VBA about-project : Model Risk Management (MRM) at HSBC is structured as a global function, headed up by the Chief Model Risk Officer (CMRO).The MRM function reports directly to the Group Chief Risk and Compliance Officer (GCRCO) ensuring its independence from the model developing and owning areas of the firm.MRM...