Quality Manager

Discover Your Impact as a Quality Manager at Reckitt

About Reckitt

Home to the world's best loved and trusted hygiene, health, and nutrition brands, Reckitt’s purpose is to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

About the Role

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. You 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 (WDAs). You will form strong working relationships with the Reckitt Nottingham and Hull sites, the UK QPs, the UK RPs, 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

• Manage Quality activities at the Reckitt Core Hub site, including management of the QMS, and maintenance of the MIA and WDA.
• Ensure 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.
• Partner with Supply, Finance, Tax, IT&D & Legal to ensure 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, partner 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.
• Manage systems and processes to enable the procurement/importation and release/sale of medicinal products.
• Establish and maintain collaborative partnerships with internal functional managers (Regulatory, Safety, Technical, R&D, Medical, Supply, Procurement) to ensure that processes remain fit for purpose.
• Support Critical Event Procedure (CEP) investigations for major non-standard and product quality issues in accordance with Reckitt internal procedures.
• Support external regulatory and third-party customer audits received by either the Reckitt ENA BV or RB NL Brands BV sites.
• Proactively ensure 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.
• Approve any subcontracted activities which may impact on GDP and ensure ongoing monitoring of supplier performance.
• Maintain the site risk register and incorporate 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.
• Ensure that all records are maintained adequately, working effectively with internal parties, manufacturing sites, third parties, external bodies, and corporate personnel.
• Manage product recalls and complaints relating to ENA BV.

Responsibilities as Qualified Person

Ensure the following QP activities are 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:

• Ensure 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.
• Comply with any additional duties and requirements of national legislation.
• Record certification in a register or equivalent document.
• Ensure appropriate arrangements for distribution and shipment are in place.
• For medicinal products for human use intended to be placed on the market in the Union, ensure 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

Ensure the following RP activities are performed in accordance with EU GDP Regulations (including Directive 2001/83/EC) and Guidelines (including 2013/C 343/01) and NL National Law:

• Implement and maintain initial and continuous training programmes.
• Coordinate and promptly perform any recall operations for medicinal products.
• Ensure that relevant customer complaints are dealt with effectively.
• Ensure that suppliers and customers are approved.
• Approve any subcontracted activities that may impact on Good Distribution Practice.
• Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• Keep appropriate records of any delegated duties.
• Decide on the final disposition of returned, rejected, recalled, or falsified products.
• Approve any returns to saleable stock.
• Ensure 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 as 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, both written and oral, and ability to forge good working relationships with internal and external customers.
• 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.

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: Understands the business environment in which the company and region operates; has an appreciation of the industry sector and competitors.
• Customer Awareness: Understands the customer base and is aware of customer requirements.

What We Offer

• 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.