Quality Manager

We are Reckitt

About the role

Job Title    Quality Manager – Reckitt Core Hub 
Reports to:    Head of Quality, Reckitt Core Hub and RB NL Brands
Location:    Amsterdam, The Netherlands

This role is responsible for Good Distribution and Good Manufacturing Practice compliance of the Reckitt Benckiser ENA B.V. and RBNL Brands B.V. sites. This role will ensure the Quality Management Systems are implemented and maintained, ensuring the compliance of medicinal products imported into the EU for onward supply.   This role is responsible for the activities relating to operational quality for the EU Supply of medicinal products. 

You will take accountability for the legal and routine duties of the QP and RP roles, and therefore need to be eligible to be named as Qualified Person on the Manufacturing Importation Authorisations (MIAs) and as Responsible Person on the Wholesale Distribution Authorisation (WDA)s. You will form strong working relationships with the Reckitt Nottingham and Hull sites, the UK QPs, the UK RP’s, the EU Supply Services and Commercial Quality teams to ensure the effective onward supply of medicines across Europe. 

A strong working knowledge of EU GMP and GDP, the ability to communicate proactively, influence with impact, clearly and concisely both internally and externally are key to this role

Your responsibilities

•    Responsible for managing Quality activities at the Reckitt Core Hub site including management of the QMS, maintenance of the MIA and WDA.
•    Ensuring that the Quality Management System for ENA BV meets internal and external requirements, providing business KPIs as per agreed schedules.
•    Establish and maintain training programmes for ENA BV
•    In partnership with Supply, Finance, Tax, IT&D & Legal, ensures all ENA BV activities including Supply chain routes are fully compliant with European legislation to minimise risk to consumers, company and brand name.
•    For NPD/EPD partnering with R&D and Category Supply to ensure Supply chain routes from factory to European markets are compliant with local legislation and guidelines and regularly reviewed .
•    Management of systems and process to enable the procurement/importation and release/sale of medicinal products.
•    Establishing and maintaining a collaborative partnership with internal functional managers (Regulatory, Safety, Technical, R&D, Medical, Supply, Procurement) to ensure that processes remain fit for purpose.
•    Supports Critical Event Procedure (CEP) investigations for major non-standard and product quality issues in accordance with Reckitt internal procedures.
•    Supports external regulatory and third-party customer audits received by either the Reckitt ENA BV or RB NL Brands BV sites.
•    Proactively ensures KPIs for team performance are reviewed and trended, identifying and implementing continuous improvement of the QMS through the identification of technology and new ways of working.
•    Approving any subcontracted activities which may impact on GDP and ensuring ongoing monitoring of Supplier performance.
•    Maintenance of the site risk register and incorporating quality risk assessment within the QMS, performing risk assessments in accordance with a local plan.
•    Lead Quality Improvement Projects within ENA BV, partnering with other functions as required.
•    Ensuring that all records are maintained adequately. The candidate must work effectively with internal parties, manufacturing sites, third parties, external bodies and corporate personnel.
•    Management of product recalls and complaints relating to ENA BV.

Responsibilities as Qualified Person

Responsible to ensure the following QP activities are being performed in accordance with EU GMP Regulations (including Directive 2001/83/EC) and Guidelines (including Annex 16 of the Eudralex Volume 4) and NL National Law. 

• The QP is responsible for ensuring that prior to batch certification, each batch has been manufactured and tested in accordance with the requirements of its local Marketing Authorisation and in accordance with the principles and guidelines of GMP prior to final market release.
• Certification is permitted under the terms of the MIA.
• Any additional duties and requirements of national legislation are complied with.
• Certification is recorded in a register or equivalent document
• The appropriate arrangements for distribution and shipment are in place.
• In the case of medicinal products for human use intended to be placed on the market in the Union, the safety features referred to in Article 54(o) of Directive 2001/83/EC, as amended, have been affixed to the packaging, where appropriate.

Responsibilities as Responsible Person
Responsible to ensure the following RP activities are being performed in accordance with EU GDP Regulations (including Directive 2001/83/EC) and Guidelines (including 2013/C 343/01) and NL National Law: 

• ensuring that initial and continuous training programmes are implemented and maintained;
• coordinating and promptly performing any recall operations for medicinal products;
• ensuring that relevant customer complaints are dealt with effectively;
• ensuring that suppliers and customers are approved;
• approving any subcontracted activities that may impact on Good Distribution Practice;
• ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
• keeping appropriate records of any delegated duties;
• deciding on the final disposition of returned, rejected, recalled, or falsified products;
• approving any returns to saleable stock;
• ensuring that any additional requirements imposed on certain products by national law are adhered to

Please note that the duties and responsibilities within this role may change over the course of employment, which will require flexibility

Key Challenges

•    Maintaining oversight of the manufacturing facilities and ability to demonstrate continued knowledge and understanding.
•    Ensuring the ENA BV site remains in compliance with current GMDP EU/NL legislation. 
•    Ensuring that batches are QP released to market following importation.
•    Responsible for the establishment and ongoing maintenance of QMS in line with GMDP EU/NL legislative requirements.
•    Preparation, management and remediation activities associated with successful Health Authority inspections for ENA BV. 

The experience we're looking for

•    Excellent working knowledge and application of Current EU/NL Guide to GMP and EU/NL GDP as well of understanding the requirements for products supplied from 3rd countries to the EU e.g. UK, Thailand 
•    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 and able to transform solid thinking into action
•    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. 
•    Excellent communication skills both written and oral, and ability to forge good working relationships with internal and external customers 
•    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 

Technical and Professional Qualifications
•    Degree or equivalent in a relevant scientific discipline.
•    Eligible to act as a Qualified Person & RP in the EU/NL
•    Minimum of 5 years’ experience within a Healthcare environment

Personal Attributes

•    Demonstrate behaviours in line with Reckitt strategic values
•    Strong leadership, communication, motivational and interpersonal skills
•    Able to train and coach others in risk assessment and auditing techniques
•    Able to lead on improvement plans for Reckitt ENA BV site 
•    Persistent and driven to achieve a final solution. A completer finisher
•    Global mindset, commercial understanding of corporate and operational business issues
•    Strong networker within and external to Reckitt with a continuous improvement mindset
•    Proven ability to work under pressure without compromising on deliverables
•    Capable of building strong working relationships and motivating teams to deliver outstanding results
•    Manages their professional development
•    Business Awareness
o    understands the business environment in which the company and region operates
o    has an appreciation of the industry sector and competitors
•    Customer Awareness
o    understands the customer base and is aware of customer requirements

What we offer

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Equality