Commercial Quality Manager
We are Reckitt
Research & Development
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.
Issues/ complaints management: For quality issues/ complaints originating in the commercial function, carry out investigation and apply corrective and preventive actions to prevent recurrence.
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 compromise the quality of products and can demonstrate compliance with GDP
Results oriented, entrepreneurial and self-motivating
Strong leadership, motivational and interpersonal skills
Capable of building strong working relationships and motivating teams to deliver outstanding results with or without hierarchical relationships
Commercial understanding of corporate and operational business issues
Strong understanding of marketing strategy, planning issues, budgeting, priority setting, project management
Ability to transform solid thinking into action (a thinker and an achiever)
Good communication skills both written and oral (in English), and ability to influence and negotiate with personnel from all functions
Strong intellectual curiosity
Appetite for exploring new and previously uncharted territories
Openness to change and ability to think out of the box
Excellent Presentation skills
The skills for success
What we offer
Equality
Job Segment:
Medical Device, Nutrition, Counseling, Healthcare