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Mgr, Continuous Improvement

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Research & Development
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185019 Requisition #
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Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.


Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

 

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients.  Power your future & join our bold team.

 

Position Overview

The Manager of Continuous Improvement – Quality partners with the senior leaders and functional managers globally across the regions in the R&D organization to support a culture of quality. Provides expertise in GxP and compliance practices to increase measured quality of development programs. 

Main Areas of Responsibilities

This position can be regionally or office based and requires travel both within and across regions. Deliverables include but are not limited to:

Assisting the Head of Continuous Improvement - Quality to support a productive, effective and efficient R&D organization, increase quality and reduce risk by:

·       Providing expertise in the application of GxP.

·       Tracking and analyzing quality indicators and working with functions to design effective improvements to address issues and gaps.

·       Facilitating cross functional learning to reduce risk to the organization.

·       Supporting audit and inspection readiness and response.

·       Regularly update regulatory, industry and company specific knowledge and continuous improvement skills

The employee is expected to be fully capable of performing roles encompassed in the preceding grade levels within the job family as required by the organization.  Other activities, special projects and assignments may be given as required.  As a result, the percentage of time spent across roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.

 

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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