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Mgr, Continuous Improvement (R&D Clinical Quality/Compliance)

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Research & Development
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185019 Requisition #
Thanks for your interest in the Mgr, Continuous Improvement (R&D Clinical Quality/Compliance) position. Unfortunately this position has been closed but you can search our 420 open jobs by clicking here.

Requirements

       Provide GxP consultation to individuals and teams and track to support visibility and consistency.

       Facilitate the development and resolution of commitments on systemic issues, critical observations, serious breach, and audit responses.

       Track quality indicators including important issues, non-compliance with SOPs or GxP, CAPAs and audit/inspection observations.

       Evaluate and utilize quality trends and available metrics to identify gaps or opportunities for improvement and communicate finding to stakeholders.

       Maintain and improve processes applicable to compliance management and provide input to R&D processes that support in-process quality control.

       Collaborate with corporate and R&D Quality Assurance to ensure alignment and information sharing.

       Engage Quality Assurance, Training, Process Development and IT support as needed.

       Communicate effectively and openly at all levels

 

In addition, the incumbent maintains key contacts within and outside of R&D including Biologics, Clinical Development, Device, Drug Development Operations, Medical Affairs, Non-Clinical and Translational Sciences, Pharmaceutical Development, Project Management & Planning, Quality Assurance, Regulatory Affairs & Medical Writing, Research and Scientific Innovation, and Safety. External interfaces include:  industry groups, various contract research organizations and other vendors or consultants.

 

       Facilitate, develop and/or deliver training on GxP related topics to promote quality and compliance across the organization.

       Train the organization on discovery, root cause analysis, improvement/correction planning and implementation.

       Improve and maintain the annual GCP training module

       Facilitate or deliver training on inspection readiness and inspection trends to the organization

 

In addition, the incumbent maintains key contacts as noted above.

 

Preferred Skills/Qualification

       Excellent understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations

       Proficient with facilitation and methods of discovery, root cause analysis, improvement/correction planning and implementation

       Proficient with trending and metrics

       Good understanding of operations and the drug development process

       Knowledge of concepts of clinical research and drug development

       Proficient with electronic systems including, Microsoft Office Suite, SharePoint, CAPA Management systems

       Ability to manage and prioritize multiple projects

       Self-starter with ability to work independently at the regional or global level with remote or minimal supervision

       Ability to work effectively in a team/matrix environment and influence others without direct reporting relationships

       Ability to understand technical, scientific and medical information

       Demonstrated strengths in:  Planning, organizational, project management and analytical skills, Oral and written communication, Time management, Negotiation, Conflict management and resolution, Problem solving, Attention to detail, Interpersonal and networking skills, Relationship building, Motivational skills, Cross-cultural sensitivity, Customer service orientation

       Ability to travel up to 30% of time 

 

Knowledge: 

       Excellent understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations

       Proficient with facilitation and methods of discovery, root cause analysis, improvement/correction planning and implementation

       Proficient with trending and metrics

       Good understanding of operations and the drug development process

       Knowledge of concepts of clinical research and drug development

       Proficient with electronic systems including, Microsoft Office Suite, SharePoint, CAPA Management systems

 

Competencies:

       Ability to manage and prioritize multiple projects

       Self-starter with ability to work independently at the regional or global level with remote or minimal supervision

       Ability to work effectively in a team/matrix environment and influence others without direct reporting relationships

       Ability to understand technical, scientific and medical information

       Demonstrated strengths in:  Planning, organizational, project management and analytical skills, Oral and written communication, Time management, Negotiation, Conflict management and resolution, Problem solving, Attention to detail, Interpersonal and networking skills, Relationship building, Motivational skills, Cross-cultural sensitivity, Customer service orientation

 

Education

       B.A/B.S. with 5 years of experience in research and development, MS/MA in related field may substitute for 1 year of experience.

       Prefer 1 year at advanced management or operations levels.

       Prefer 3 years directly assessing and improving quality.

 

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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