HireDiversity

Zug, CH

Global Quality Application Lead — Compliance Wire (EMEA and APAC)-00000A0U

Description

The Sr. Specialist, Learning Management System lead is the regional business owner for ensuring that that the LMS Compliance wire is maintained in a validated state of compliance. This person serves as the Company's Subject Matter Expert on the system, and will work within a cross-functional team comprised of business, Quality and Compliance and IT stakeholders from J&J Consumer globally, to monitor system functional performance, manage access controls, manage system master files, and ensure the compliant use of the system.

- The Learning Management e-systems lead is responsible for developing, implementing and training on the use of Compliance wire as the Consumer Sector application for GxP Training.
- Establishes the standards for Compliance Wire data segregation and denomination by region and by location to ensure accuracy and organization in the system.
- Train, Qualify and provide access to the regional administrators of Compliance Wire and or training site leads.

PRINCIPAL RESPONSIBILITIES

- Ensure that site training programs are deployed accurately in alignment with current standard operating procedures
- Liaise, guide and work with regional training site leads to identify areas for improvement in training and eLearning programs ensure harmonization of practices across sites
- Create and manage regional and global LMS User Groups and curricula. Coordinate with Local Training Leads the addition of the specific users into these groups and assignments for the global / regional curricula.
- Regional Training Process Owner who provides regional audit/Inspection support with regional training management questions and training records
- Manage the creation of harmonized training courses with SMEs across the region
- Reviewing and approving eLearning modules for WWSPs, QSPs and global SOPs and facilitate the creation training assessments.
- Organize and manage the creation and delivery of regional GxP concept training
- Maintain J&J Training Server for regional training materials, including GxP training programs
- Create and manage the global training curricula and assignments ensuring that they are current, accurate and deployed in alignment with current training processes. This may include, but is not limited to, consulting on and/or defining the eLearning strategy and creating/reviewing training materials for global quality applications.
- Act as the Training Process expert and assist at deploying processes at local sites
- Deploy a standardized program for Train-the-Trainer in his/her region.
- Deploy and administer the TTT program for their region.
- Identify training gaps, resolve problems and drive process improvements with local training leads and local management
- Act as the author for regional training/e-system administration procedures.
- Manages the development and deployment of all regional and work with other regional leads in the development and deployment of global training initiatives
- Deploys the standards of evaluations to local sites
- Performs and manages the deployment and documentation of on-going training gap assessments for the region of responsibility

Qualifications


KNOWLEDGE SKILL AND ABILITY REQUIREMENTS

- Associate's Degree required, BS/BS desirable
- 3-5 years of related experience
- 2 years system admin or comparable experience in a controlled environment
- Experience with administrating regulated LMS applications
- Understands and has experience of Computer System Validation and 21 CFR part 11 requirements
- Ability to assess multiple issues, and interpret the compliance and business impact, translating into system and process requirements
- Capability to focus and prioritize, with the ability to multitask in a fast paced dynamic global environment
- Trains others ensuring effectiveness of understanding based on the users capability and role
- Strong Customer focus, maximizing users experience, reducing bureaucracy and ensuring compliance in execution

COMPETENCY REQUIREMENTS

- Knowledge of cGMP's and basics in quality processes is required
- Good knowledge of Microsoft applications (Word, Excel,…)
- Excellent communication skills
- Ability to prioritize tasks and work independently
- Customer Focus
- Technical Writing experience
- A high level of accuracy and commitment to timeframes
- Strong analytical and problem solving skills

QLD Competencies

- Autonomy - works independently on complex issues. Serves as Subject Matter Expert for system.
- Customer Focus - maximizing users experience, reducing bureaucracy and ensuring compliance in execution.
- Masters Complexity - Capability to focus and prioritize, with the ability to multitask in a fast paced dynamic global environment.

Manages Complexity

- Thinks analytically to understand a situation, an issue, or a problem
- Acts decisively setting clear priorities
- Maintains focus and composure in uncertain circumstances
- Makes the complex clear and easily understood by others
- Provides steady leadership in a complex situation

Implements Positive Change

- Recognizes and builds support for change
- Models the change expected of others
- Effectively manages resistance to change
- Engages in constructive conflict

Forges a Vision of the Future

- Visualizes and clearly communicates a vision of the future to the entire organization
- Inspires enthusiasm and commitment in others to achieve the vision
- Demands the pursuit of stretch goals for self and others

Collaboration/Builds Interdependent Partnerships

- Continuously broadens and maintains a wide network of relationships
- Actively leverages and shares resources, processes and best practices across the business
- Establishes mutually beneficial objectives and accountabilities to achieve goals
- Communicates openly and frequently with partners
- Demonstrates commitment to the partnership in both words and actions
- Anticipates the impact of decisions and actions on others
- Leverages the global diversity of Johnson & Johnson to drive business success
- Functions as both team player and leader
- Demonstrates global business and organizational savvy
- Builds consensus and impacts outcomes with limited authority

EXTERNAL AND INTERNAL INTERACTIONS

Internal: Directors and Vice presidents across multifunctions and sectors. Consumer Sector CQO, Enterprise VP and Director level. Strong participation on cross sector teams and initiatives
External: Will represent the business for IT Applications during Health Authority Inspections

AD CODE: J2W: JOBSCH

Primary Location:Europe/Middle East/Africa-Switzerland-Zug-Zug
Other Locations:Europe/Middle East/Africa, Asia Pacific
Organization: Cilag GmbH International (8525)
Job Function: Compliance