Associate Director Clinical Auditing

Vor 3 Tagen

Boudry, Schweiz Bristol Myers Squibb Vollzeit

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

**The Associate Director (AD) will work in the RDQ-CTQA group. This group conducts Good Clinical Practice (GCP) audits off clinical investigator sites, vendors, internal systems/processes; lead/collaborate on due diligences and pre-qualification audits. The AD will also act as an expert in specific GCP related areas and may manage Health Authority Inspections as assigned.**:
**Key Responsibilities and Major Duties**:

- Perform GCP audits of clinical investigator sites, GxP vendors and/or internal systems including pre-qualification audits to assess regulatory compliance (is a Lead auditor for a wide range of audit types)
- Acts as a strong technical resource/expert for several GCP and/or R&D topics within CTQA and function as SME to internal customers, as well as to regional and functional lines, RDQ, and stakeholders
- Drives quality improvements with stakeholders
- Support other areas within RDQ in the creation and maintenance of project/study audit plans; prior to and post audits by sharing newly identified risks to be explored in future audits
- Coordinate/Manage local and major markets HA inspections as assigned
- Represent CTS on stakeholder initiatives or in a regional improvement or quality related initiative
- May influence the external environment through interactions with regulators, trade associations, or professional societies
- Perform audit report review as management representative
- Represent department on due diligence activities for vendors and business partners
- Lead non-compliances and alleged cases of scientific misconduct investigations as assigned
- Called upon to resolve GxP issues and provide direction or strategy relative to technical expertise
- Assesses and supports the implementation of emerging regulations based on areas of technical expertise
- Able to function as a member of GCP Quality Council or equivalent/other

**Competencies***
- University Graduate in relevant discipline (life sciences degree preferred
- Comprehensive working knowledge of principles and concepts of QA, including those related to QRM, critical thinking and QbD (Quality by Design)
- Comprehensive GCP auditing and inspection management skills covering a wide range of specialized auditing functions for a specific technical area(s)
- Comprehensive knowledge of ICH-GCP Guidelines and other international GxP regulations, as appropriate
- Recognized as a Subject Matter Expert (SME) on a specific area with in depth and or breadth of expertise; e.g. technical, compliance
- other disciplines
- and or geographic regional expertise
- Detailed understanding of the drug development process and risk analysis
- Broad working knowledge of other disciplines in stakeholder organizations influence and support improvements in products, processes and services
- Minimum of 6 years in clinical QA auditing and / or 8 years of work experience in clinical research and/or GCP related QA environment
- Demonstrates excellent critical thinking skills and ability to make ethical, scientifically sound recommendations or decisions for GCP audit findings or issues consistent with company policy, regulatory references and business strategy.
- Excellent verbal and written communication skills including ability to clearly articulate information and interact effectively with auditees, stakeholders and customers from different levels across R&D including senior management
- Excellent negotiation and influencing skills of own team and key stakeholders decisions outside of the team and leveraging established relationships/networks
- Fluent in English and other languages as applicable to assigned region of responsibility
- Demonstrated strength in anticipating, evaluating and solving multiple problems with varying degrees of complexity for CTQA and stakeholder functions
- Demonstrated strength in making tactical decisions and contributing to strategic decisions involving cross-functional teams/situations
- Maintains the confidentiality and security of information, data, documents and records
- Fosters an environment that nurtures open dialogue and encourages people to raise and discuss critical issues
- Understands interdependencies
- Escalate issues to appropriate people within department/organization
- Demonstrates commitment to delivering high-quality work product
- Able to function independently within an environment that relies heavily on technology for information and communication
- Sense of diplomacy and discretion
- Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment

Bristol Myers

  • Associate Director Biostatistics

    vor 2 Wochen

    Boudry, Schweiz Proclinical Vollzeit

    Proclinical are recruiting an Associate Director Biostatistics for a pharmaceutical organisation. This role is on a permanent basis. The client is focused on to aid patients overcome serious illnesses by finding, evolving and distributing novel treatments. **Responsibilities**: - Partake in planning the evolvement method that will enable an efficient and...

  • Associate Director, Regional Clinical Compliance

    Vor 2 Tagen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...

  • Associate Director, Biostatistics

    Vor 5 Tagen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...

  • Associate Director, Operations Portfolio Lead

    vor 2 Wochen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Associated Director, Clinical Data Management

    vor 2 Wochen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Associate Clinical Trial Physician, Oncology

    Vor 2 Tagen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Market Access/heor Gbds Associate Director

    Vor 4 Tagen

    Boudry, Schweiz Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Market Access/heor Gbds Associate Director

    Vor 3 Tagen

    Boudry, Schweiz Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Associate Director, Clinical Operations Lead

    vor 1 Woche

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...

  • Associate Director, Intercontinental Scientific

    Vor 3 Tagen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...

  • Market Access/HEOR GBDS Associate Director, Boudry

    Vor 2 Tagen

    Boudry, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Market Access/HEOR GBDS Associate Director, BoudryClient: Bristol Myers SquibbLocation:Job Category:OtherJob Reference:6be204652296Job Views:4Posted:21.01.2025Expiry Date:07.03.2025Job Description:Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But...

  • Executive Director, Clinical Development Team Lead

    vor 2 Wochen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu...

  • Executive Director, Clinical Development Team Lead

    vor 2 Wochen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Market Access/HEOR GBDS Associate Director

    Vor 2 Tagen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Associate Director Intercontinental Strategy Lead

    Vor 3 Tagen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...

  • Senior Manager, Clinical Data Management

    vor 1 Tag

    Boudry, Schweiz TN Switzerland Vollzeit

    Senior Manager, Clinical Data Management, BoudryClient:Bristol Myers SquibbLocation:Boudry, New JerseyJob Category:OtherJob Reference:e6e57ac49e2fJob Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:Description: Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected...

  • Director, Early Clinical Development

    Vor 6 Tagen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Clinical Scientist Team Lead

    Vor 4 Tagen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...

  • Associate Director, Cell Therapy, Medical Communications

    Vor 2 Tagen

    Boudry, Schweiz TN Switzerland Vollzeit

    Associate Director, Cell Therapy, Medical Communications, BoudryClient: Bristol Myers SquibbLocation: Not SpecifiedJob Category: OtherJob Reference: 964006e12a49Job Views: 10Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working...

  • Associate Director, Intercon Value

    Vor 3 Tagen

    Boudry, Schweiz Bristol Myers Squibb Vollzeit

    At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...