HireDiversity

Ann Arbor, MI, US

Quality Systems and Compliance Lead-9339121116

Description

Wellness & Prevention, Inc., a Johnson & Johnson company, is currently recruiting for a Quality Systems and Compliance Lead located either in Ft. Washington, PA or Ann Arbor MI.

Wellness & Prevention, Inc., a Johnson & Johnson company, helps organizations renew the health, energy, and performance of their employees and members, and offers an integrated portfolio of solutions to cover the full spectrum of population health - from wellness and prevention, to behavioral health, to chronic disease support. These solutions include culture of health assessments and programs, on-site health screenings, Energy for Performance training, health risk assessments, user portals, incentive solutions, Digital Health Coaching, telephonic coaching, on-site health coaching, participation and engagement strategies and programs, outcomes reporting, and data analytics. Wellness & Prevention solutions are supported by a unique, integrated, and scalable approach designed to help lower health care costs, drive business performance, and enhance employee satisfaction and success.

For more information, visit www.wellnessandpreventioninc.com.

The Quality Systems and Compliance Lead will be responsible for ensuring the robust implementation and sustainability of the compliance programs designed to protect our customers, the company, and individual employees against potential quality, legal, compliance, privacy and medical risks related to promotion of services and health information management. This individual will perform quality systems support duties including maintenance of training, issue management, document control and corrective action and preventive action (CAPA) systems to ensure consistent, defined processes and measures.

Main duties and responsibilities include but are not limited to: tracking Regulatory Compliance requests and applications and govern the escalation of legal and compliance decisions to standards and policies. The Quality Systems and Compliance lead will also be responsible for centrally managing the organization's quality systems, including training, issue management, document control, and CAPA. They will also manage the Copy Clearance Review process to ensure compliance of customer-facing material to internal policies, industry guidance and government regulations. This individual will manage the risk-based framework for all compliance decisions and will track performance and cost associated with decisions requested. They also will coordinate the routine quality management review process. The Quality Systems and Compliance Lead will also guide staff in standard operating procedures management, document flow, archiving and regulatory practices.

Qualifications


A minimum of a Bachelor's Degree plus 6 years of relevant experience OR a minimum of a High School diploma combined with at least 10 years of related Quality and Compliance experience is required. Previous experience and a thorough knowledge and understanding of Privacy Regulations, Internet Compliance and/or Legal Compliance is required. Project Management experience is highly preferred. Project Management and/or Professional Quality certification(s) is preferred. Previous Quality Systems experience including Training (logistical set up and execution), Issue Management, Corrective and Preventative Action (CAPA), Quality Management Review and Root Cause analysis is required. Previous experience creating, implementing and managing the processes for the previously mentioned Quality Systems is highly desired. Proficiency with MS Office is required. Excellent verbal and written communication skills are required.

This position can be located in either Fort Washington, PA or Ann Arbor, MI and may require 10% travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Michigan-Ann Arbor
Other Locations:North America-United States-Pennsylvania-Fort Washington
Organization: Wellness & Prevention, Inc. (6173)