Commercial Quality Manager

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: 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.

**Research & Development**:

- In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

**About the role**:
**Your responsibilities**:
**LOCAL QUALITY MANAGEMENT SYSTEM (QMS)**

Responsible to support the GM’s and their management teams to enable them to develop and implement the local Quality Management System (QMS) to ensure fully compliant products.

Work with local functions to develop and maintain all relevant procedures in line with the requirements of the Reckitt Quality Manual, associated policies, relevant codes of practice and GMP/GSDP and local requirements.

Ensure that QMS is maintained in a state of compliance and inspection readiness.

Ensure processes are in place to assess the adequacy and effectiveness of the local QMS.

Ensure that improvements to products and procedures can be identified and fixed.

The individual should understand:
The current regulations related to Medicines/Medical Devices/Health Food/Cosmetics and Hygiene products in relation to storage and distribution.

Good Storage and Distribution Practice for Medicines and Medical Devices

**SPECIFIC INVOLVEMENT IN QMS PROCESSES**

Change Management: Facilitate the development and maintenance of robust and effective locally-based change control system to ensure compliant Market Authorizations.

Train all staff in commercial organization on the requirements of GMP/GDP and the Reckitt Quality Manual & associated policies.

Product Recall - as per the Critical Quality Events and Product Recall SOP establish and communicate responsibilities. Participate in mock recall exercises to confirm adequacy of the local recall procedure.

Internal audit: Responsible for implementing the local audit program covering country businesses, 3 rd parties, embellishers and other service providers under scope of responsibility.

Maintain a Fit-For-Purpose QMS: Report level of compliance of local QMS versus Reckitt Quality Manual, Policies and GMP regularly to GM’s and drive closure of gaps to maintain compliance.

DC’s and EMBELLISHERS

Responsible for initial compliance assessment and approval of Distributors & Embellishers handling RB Products.

Support the preparation of Technical Agreements (TAs) for Distributors & Embellishers - ensure all quality expectations are included (e.g. change management, deviation management, product handling, product release, responsibilities).

**INTERFACE WITH REGIONAL/SUPPLY QUALITY**

Work with regional and Supply Quality teams to ensure implementation of appropriate controls to ensure consistent quality of products

Work with the regional and Supply Quality teams to analyses country product data, CAPA and post-market surveillance information to facilitate Annual Product Quality Reviews.

**SUPPORT INSPECTIONS BY REGULATORY AUTHORITIES**

Support local business units in the preparation for and responses to inspections by Regulatory Authorities. Ensure that any CAPA is resolved in a timely manner.

**The experience we're looking for**:
Degree of pharmaceutical sciences or degree of sciences

At least 5 years of experience working in a quality and or regulatory compliance function in a Nutrition, Healthcare, Hygiene, Pharmaceutical, FMCG, or Medical Device related industry.

Experience in developing and maintaining a robust QMS in a Nutrition, Healthcare, Hygiene, Pharmaceutical, Food, or Medical Device related industry.

Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks.

Understanding of typical regulatory requirements relevant to a regulated product e.g. GDP, EU GMP, WHO, PIC/S, CFR 21 Part 111/ 210/ 211/ 820

Clear understanding to ensure operations do not co