GMP Compliance Co Ordinator chez Gsknch

Job Description:

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

With category leading brands such as Sensodyne, Panadol and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

About the role

The purpose of this job is to co-ordinate site activity to provide leadership in the area of GMP compliance to enable a constant state of Inspection readiness. The scope of this job description incorporates the responsibilities of the GMP Compliance Coordinator

Key Responsibilities

Process Owner/Coordinator for relevant process as follows:

• Regulatory, Notified Body and Contract Giver Inspection Management / Readiness
• Management Review/Quality Council
• Quality Metrics o
• Quality Alerts & Bulletins
• GMP training o Halal Product Assurance System (HPAS) Implementation - Halal Coordinator
• Management Monitoring o Quality Alerts
• Periodic Product Review (Back-up SME)
• Gowning Procedures
• File Share Management

Procedure update, review and approval / Continuous improvement in Quality team processes

Area Quality Representative support to other departments

Support / input to the following processes as required:

• Internal Audit (IBM) Quality Regulatory Intelligence, Documentation Management, CAPA Management, Change Control, Haleon Quality System Implementation

Continuous improvement in RFT/ compliance

Understanding of appropriate Directives, Standards, Quality Managements Systems related to the manufacture of Medical Device and Medicinal products for required markets; including:

• Annex II including section 4 of UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) o Annex IX of EU Medical Device Regulation 2017/745
• EN ISO 13485:2016+A11:2021 o Pharmaceutical and Medical Device Act, (2024) Japan
• MHLW Ordinance No 2, 169
• Haleon QMS Policies and Procedures
• Eudralex Volume 4 & applicable annexes
• ICH Guidelines
• Technical Regulations for Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine October 2nd, 2013, No.753
•  Halal Product Assurance System (issued by Halal Product Assurance Body (BPJPH Indonesia)
• U.S. Food and Drug Administration 21 CFR Part 820, 210/211
• Quality System Regulation
• Korean Good Manufacturing Practice (GMP) for Medical Devices (2023)
• China Good Manufacturing Practice for Medical Devices
• Misuse of Drugs Acts & Regulations

Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements

• Participate fully in our site’s quality initiatives and ensure that all relevant quality standards are adhered to
• Maintain GMP standards where appropriate to your role
• Read and understand relevant HQS Standards and CH SOPs applicable to role
• Attend training and complete assessments as required o Ensure Quality and GMP are at the forefront of changes proposed
• Ensure Halal requirements are met in accordance with Halal Product Assurance System (issued by Halal Product Assurance Body (BPJPH Indonesia) for applicable Medical Device products/markets
• Support site HAPs projects

Inspection Readiness:

• Lead inspection readiness initiatives across the site or organization.
• Develop and maintain inspection readiness plans, tools, and checklists.
• Conduct and support GEMBA  to identify areas for improvement.
• Provide training and guidance to staff on inspection behavior and regulatory expectations.
• Support the development and review of documentation to ensure inspection readiness.
• Act as a point of contact during regulatory inspections, supporting SMEs and leadership.
• Track and report inspection readiness metrics and progress to senior management.
• Collaborate with Quality Assurance, Regulatory Affairs, and other departments to ensure alignment.
• Stay current with regulatory trends and inspection findings across the industry.
• Manage all inspection logistics including:
• Setting up and maintaining inspection rooms and breakout areas.
• Coordinating IT support and ensuring systems (e.g., Veeva) are inspection-ready.
• Booking rooms, arranging transport and transfers for inspectors when needed.
• Managing inspection schedules and ensuring smooth daily operations.
• Acting as point of contact for inspectors and facilitating real-time responses.
• Ensure timely initiation, tracking, and closure of inspection findings and commitments.
• Maintain inspection documentation, trackers, and communication logs.
• Communicate inspection timelines, expectations, and updates to site personnel.
• Collaborate with Quality, Regulatory, and other departments to ensure alignment.
• Support leadership and SMEs during inspections, including briefing and debriefing sessions.
• Provide post-inspection summaries and lessons learned to drive continuous improvement

Ability to communicate with a wide variety of people at all levels both within the site and externally through appropriate skills:

• Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listening. o Demonstrated ability to problem solve
• Demonstrated ability to effectively plan work and to manage projects EHS
• Perform duties in a compliant manner and behave in accordance with site SOP’s, Haleon EHS standards and guidelines and relevant legal requirements
• Read and understand Standard Operating Procedures applicable to role
• Report all accidents, incidents and any EHS issues using the appropriate process /system to your line manager or, if required, the Occupational Health Advisor.
• Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards.
• Be aware of the impact of your job activities on EHS issues Haleon QD-REC-028101 v: 12.0

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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