Regulatory Job 581074-QARA Training Manager

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581074-QARA Training Manager WI 30 - 100k (J#13320)
Education: Bachelors Degree
Experience: 4 - 9 years

Essential Functions (Responsibilities):
The QARA Training Manager for Clinical Systems (CS) is responsible for the development, execution and validation of the QA and RA training and development strategy/framework and resulting programs and processes for the global CS organization. In addition, the incumbent is responsible for assuring training programs support a regulatory compliance culture at GEHC CS through skill based learning and required employee knowledge. The Training Manager will be responsible for ensuring all training is compliant with GEHC's Quality Management System and all applicable medical product regulations (FDA, EU, etc). This position will require maintaining an up-to-date knowledge of medical product regulations to ensure that GEHC Clinical Systems training programs are current and employees are trained and aware of the latest regulatory requirements.

Key responsibilities include:
-Formulate the strategy, priorities, plans, recommendations and deployment of standard and consistent QA training.
-Establish procedure for a) identifying individual training needs, b) ensuring appropriate personnel are trained, c) individual training needs and plans are documented and readily available.
-Conduct skill gap assessments and address through necessary education and training.
-Understand critical skills and abilities required to perform a role within the context of quality and compliance.
-Ensure all levels of employees have knowledge, skills, and abilities to consistently perform their job at a high level of compliance and performance.
-Develop training content and delivery mechanisms and methods for different types & segments of training.
-Work closely with the leadership within the CS QA/RA organization to ensure their training needs are being met.
-Work with the central QA/RA training team on the development and deployment of all QA/RA training to ensure they are consistent with the global vision for QA/RA training across GEHC.

Qualifications/Requirements:
1. Bachelor's degree and minimum of 5 years working experience in Quality Assurance/Regulatory Affairs or managing training activities across an organization. Alternatively, a High school diploma/GED and minimum of 7 years working experience in Quality Assurance/Regulatory Affairs or managing training activities across an organization.
2. Demonstrated experience working in a regulated environment, requiring adherence to government or regulatory body policies and procedures.
3. Demonstrated project management experience developing processes and leading their implementation in a cross functional environment.
4. Demonstrated ability to lead and influence behavioral change in a matrixes environment
5. Demonstrated ability to effectively communicate (oral and written using English) across a cross-functional organization, up to business leadership and down to individual contributors.
6. Demonstrated experience successfully working with teams across many, cultures and/or work sites.
7. Ability to travel domestically and internationally as needed.
8. Prior experience and proficiency with word processing, spreadsheet, and presentation software
9. You must submit your resume through gecareers.com or a job board to be considered for this specific job opening (internal candidates should apply through COS).
10. Must be willing to take a drug test as part of the selection process
11. Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background
12. You must be legally authorized to work in the United States without work sponsorship at time of hire.
13. Must be willing to work in Wauwatosa, Wisconsin.
Desired:
1. Master's degree and 7 years experience developing, implementing and leading training activities
2. Prior Experience in Quality Assurance in Medical Device or Pharmaceutical industry
3. Familiarity with FDA, QSR, ISO 13485, training in a regulated industry, and other quality system regulations

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