Sr. Manager QMS Life Cycle

 

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Sr. Manager QMS Life Cycle 

 

Senior Manager QMS Life Cycle – Morristown, NJ

PURPOSE:

This position is responsible for designing, developing, implementing and managing an effective GMP training process for US Commercial Operations employees in accordance with SOPs, industry and Bayer corporate standards, and FDA regulations. The position will provide quality oversight for local GxP relevant IT systems maintaining the systems’ validated states. The position will support critical event and quality issue management, recalls, withdrawals as well as technical safety-relevant topics in cooperation with US Product Quality Safety Committee (PQSC).

 

KEY TASKS AND RESPONSIBILITIES

• Ensures the GMP training program for US Commercial Operations employees is in compliance with FDA regulations, SOPs, industry and Bayer corporate standards;
• Accountable for all aspects of the US Commercial Operations GMP training program:
  • Develops and maintains learning plans for import into the LMS (My Learning);
  • Designs and develops eLearning training materials for distribution via the learning management system (LMS) including effectiveness checks;
  • Tracks local training to completion, and develops and maintains training relevant KPIs;
  • Maintains all documentation related to GMP training for the US Commercial Operation throughout the required retention period;
• Acts as the point of contact for all communication between US Quality and the Commercial Organization regarding the GMP training program;
  • Responds to inquiries and requests for support received via the US Country Quality mailbox;
  • Collaborates with US Corporate Communications regarding communication initiatives from US Quality to the Commercial Organization;
• Ensures the regulatory compliance and validated state of locally managed GxP relevant IT systems:
  • Provides Quality oversight, regulatory guidance, independent review and approval of life cycle documentation, validation deliverables, and change management documentation to maintain the validated state of local GxP IT systems in compliance with FDA regulations, SOPs, industry and Bayer corporate standards;
• Responsible for submission and interaction with FDA regarding Field Alert Reports as determined by VP of the Quality, Division Quality Head and the PQSC;

 

REQUIRED QUALIFICATIONS

• BA/BS in life sciences;
• Minimum of 7 years of professional business experience in pharmaceutical (or related healthcare industry);
• Experience managing curricula driven training program via an LMS;
• Experience overseeing a computer system validation process including ongoing validation maintenance;
• Excellent interpersonal skills and the ability to interact constructively with all levels of management internally and externally both in the domestic and international arenas;
• Ability to focus on outcomes that support compliance and ensure quality products for our customers;
• Action oriented with the ability to learn fast and adjust to support required outcomes.

 

PREFERRED QUALFICATIONS

• Experience in a Quality Assurance, Quality Control or Manufacturing environment.

 

Bayer is an Equal Opportunity Employer/Disabled/Veterans

   

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.  

      If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.                     Division: Pharmaceuticals   Reference Code 818787   Functional Area: Information Technology   Location: United States : New Jersey : Morristown Employment Type: Regular  Position Grade: VS 1.2       Contact Us   Address Telephone E-Mail Creve Coeur, MO +1 888-473-1001, option #5 hrop_usa@bayer.com 63167