Change Control Lead

Job description

Job title : Change Control Lead

About the Job:

Main responsibilities:

Mission

The Change Control Lead defines and maintains the requirements of the processes for the CHC QMS to:

Ensure adherence of CHC sites, External Manufacturing Entities, Global GxP Functions and local affiliates worldwide to current legal quality / GMP authority requirements and norms. Assure implementation of emerging regulatory requirements into global processes in alignment with the involved CHC functions (Quality, including Country Quality, Science Hub GxP functions), as appropriate Develop digital tools (Business System Owner role), processes (Business Process Owner role) and trainings for the assigned Quality System

Execute the corporate business strategy in the area of responsibility

Leads transversal projects in the area of responsibility

Provide leadership and active support to operative units for quality and compliance related topics and projects, including Digital Application roll out.

Potential Specific Domains

The role requires specific experience and expertise in the field of:

·  Knowledge / experience / expertise in the field of:
·  Change Control
·  Quality Management System
·  Applicable regulation relevant for CHC (EU GMP, FDA cGMP, Nutraceuticals, Medical Devices)
·  Computerized Systems Compliance (in GxP area)
·  Cross functional / transversal management
·  Project management

Key Contributions & Activities

Definition of processes:

·  Authors the CHC Global Quality Documents for the assigned QMS in collaboration with the impacted functions
·  Provide the trainings
·  Drives continuous improvement
·  Define the backlog for the assigned QMS in collaboration with the impacted functions
·  Prioritize the backlog in alignment with the functions and with the digital product owner
·  Integrates Risk Management principles into Quality systems
·  Implements harmonized processes in the CHC QMS solution.
·  Authors user requirements
·  Identifies risks (functional risk assessment) and perform tests
·  Ensure system’s compliance along life cycle
·  Establishes adequate KPIs for data analysis, trending and reporting.

Tools:

·  Develops tools for supervising and optimising the overall efficiency of transversal processes in his / her area of responsibility including interfaces

Transversal activities

·  Develop and maintains a network with sites, external manufacturing, affiliates, global GxP functions (function involved in the assigned systems) with best practice sharing and cross fertilization
·  Develops the adequate quality documents/training materials relative to processes ways of working and tools to support

Scope of Responsibility

Management Responsibilities

No Solid line management.

The role holder is required to work autonomously and to make decisions in line with the Global Quality Policy, Standards and Processes. The role holder has strong compliance mindset, is results-driven, demonstrates can-do-attitude.

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