Associate Director Clinical Trial Systems and
vor 2 Wochen
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.
- Perform GCP audits of clinical investigator sites, GxP vendors and/or internal systems including prequalification 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 noncompliances 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
Requirements:
- 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 within depth and or breadth of expertise, e.g. technical, compliance
- 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
We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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