Quality Manager overseeing GMP and GDP compliance at Reckitt's Core Hub in Schiphol. Leading Quality Assurance activities and ensuring effective supply of medicinal products across Europe.
Responsibilities
Accountable for managing all Quality activities at the Reckitt Core Hub, including oversight of the Quality Management System (QMS) and maintenance of the MIA/WDA
Lead the Quality Assurance team, ensuring all requirements are met prior to batch certification, with direct management of three reports
Ensure the ENA BV QMS meets internal and external standards and deliver business KPIs per agreed timelines
Develop and maintain training programmes for ENA BV
Partner with Supply, Finance, Tax, IT&D and Legal to ensure that all ENA BV operations and supply chain routes comply with European legislation
Collaborate with R&D and Category Supply to ensure supply routes meet local regulatory expectations
Manage systems enabling procurement, importation, release and sale of medicinal products
Establish and maintain strong partnerships with internal stakeholders to ensure compliance and effectiveness
Support Critical Event Procedure (CEP) investigations and audits affecting ENA BV or RB NL Brands BV
Review and analyse performance KPIs, driving continuous improvement of the QMS
Approve subcontracted activities affecting GDP and monitor supplier performance
Maintain the site risk register and integrate quality risk assessments within the QMS
Lead Quality Improvement Projects within ENA BV
Oversee product complaints and recalls
Requirements
Excellent working knowledge and application of Current EU/NL Guide to GMP/GDP
Strong leadership, partnership and facilitation skills
Capable of working both vertically and horizontally within the organisation
Strong ability to think strategically, develop tactics and measurable implementation plans
Excellent communication and presentation skills
Previous experience within Quality Assurance, creating or reviewing policies and procedures, internal auditing, reviewing deviations, change control requests, CAPA etc.
Calm, systematic, logical thinker, with ability to focus on priorities whilst coordinating multiple issues
Commitment to quality, patient safety and achieving the best outcome with a pragmatic and strategic approach
Degree or equivalent in a relevant scientific discipline
Eligible to act as a Qualified Person/Responsible Person in the EU/NL
Minimum of 5 years’ experience within a Healthcare environment
Benefits
Parental benefits
Employee Assistance Program to promote mental health
Life insurance for all employees globally
A range of other benefits in line with the local market
Global share plans giving an opportunity to save and share in Reckitt's potential future successes
Short-term incentives to recognize, appreciate and reward work for delivering outstanding results
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