Onsite Quality Manager

Posted last week

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About the role

  • 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

Job title

Quality Manager

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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