R&D Quality Manager, Compliance

Overview

The R&D Quality Manager Audit Lead leads the R&D vendor approval for the clinical and quality compliance pillar within the Europe Vendor Quality Team. The role manages all activities associated with the audit programme and related documentation for GxPs (GCP, GVP, GMP) within R&D. The audit team provides support to global R&D colleagues, providing SME audit support when required. The role may also be required to support supplier qualification and audit activities for the wider European Vendor Quality Team, Corporate Audits and release activities and related compliance activities for R&D Hull.

• Management of External Compliance activities for R&D for all GxP and Core Reckitt products.
• Ability to 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.

• 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.
• The skills for success:
  Commercial Awareness, Business Partnership, Collaboration, Partnership building, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Collaborator, R&D, Product Lifecycle Management.