QMS Transformation and Training Specialist
Location:
Westlake Village , California
Posted:
February 03, 2017
Reference:
5008Y3


Description
Primary Responsibilities:
This quality position is responsible for supporting full deployment of a transformed Quality Management System for the Shire sites. The individual will help develop and deploy the change management plan and support needed to be successful. The individual and team will frequently visit the manufacturing sites to understand and mitigate any deployment challenges, and to coach the sites on the new Mindset behind the transformed system: being more flexible, nimble, and innovative. Also responsible assuring solid training in GMPs for operations.

Responsibilities:
QMS Deployment Support (60%)
Training, Quality Comprehension (40%)
  • Be a change agent in support of continued improvement in nimble and flexible quality systems. Also manage the Compliance training support team.
  • Ensure full and sustained deployment of newly integrated, transformed Quality Management System Elements ensuring compliance to regulatory requirements; and driving consistency with corporate standards.
  • Help develop and deploy strategies to assure understanding (Mindsets) of the behaviors and tactic in executing against thee quality systems.
  • Partner with key stakeholders, e.g. manufacturing, engineering, vigilance, regulatory, PSTO, etc. to assure the deployment of an overall effective quality system.
  • Communicate significant quality systems issues to senior management
  • Attend weekly Global PMO meetings
  • "Walk the halls" at each site/entity within a region; actively look for opportunities to engage employees in their decision-making and reinforce the quality principles
  • Attend on-site "decision review meetings" led by local managers and supervisors to course-correct behavior
  • Work with Core Team to develop action plans for sites that are off-track in adopting the change
  • Continually assess and analyze all elements of the quality systems and recommend actions to improve them.
Education and Experience Requirements:
Essential:
  • Bachelors degree in a science related field
  • 5-8 years quality leadership experience in an FDA regulated industry

    Desired:
  • Master Degree in science or Quality Assurance
  • ASQ Certified Quality Manager
  • Experience with Medical Devices, Biologics, Blood Products, and small molecules
Experienced in a role responsible for developing and deploying GMP training

Qualifications

Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Supplement
Pay Transparency Policy
Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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