R&D Quality Manager leading vendor approval for clinical and quality compliance in R&D. Responsible for managing audit activities and ensuring adherence to global compliance standards.
Responsibilities
Management of External Compliance activities for R&D for all GxP and Core Reckitt products
Collaborate with the global audit network to deliver the external audit programme and approve new vendors/ suppliers to R&D
Acts as an audit subject matter expert and support global R&D audit teams
Provide quality support for compliance activities including deviations, change controls and risk management relating to vendor quality management
Actively participates in quality culture and continuous improvement activities
Support the technology transfer process from R&D to commercial manufacture
Proactively monitors and responds to changes in guidance and legislation issued by Regulatory Authorities
Provides data and information to communicate supplier and supplier quality management performance at Quality Management reviews
Requires travel to global Reckitt sites and 3rd party vendors
Ensure data integrity compliance
Support and ensure GxP systems are compliant to global policy and procedures and regulatory standards
Requirements
Trained and experienced lead auditor
Degree in a scientific discipline is required
Experience of working in a Quality environment for product development is essential
An appreciation and understanding of global medicines regulations is required
Previous line management experience is required
Ability to work cross functionally with global R&D teams and form collaborative relationships
Experience across a broad range of therapeutic areas and product classifications is desired
Ability to critically apprise Quality impacting regulatory guidance and legislation for internal action
Strong project management and organisational skills
Benefits
Parental benefits
Employee Assistance Program to promote mental health
Life insurance for all employees globally
Opportunity to save and share in Reckitt's potential future successes
Short-term incentives to recognize, appreciate and reward work
Job title
R&D Quality Manager, Compliance – 12 Month Fixed Term Contract
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