Trading Partner Quality Manager
GSK is looking for Trading Partner Quality Manager to join our Consumer Healthcare Quality team.
The Human Medicines Regulations require a distributor to designate a Responsible Person(s), named on the applicable licence. Regulation 45 and the EU GDP Guide set out the requirements and the responsibilities.
In this role, you will be the UK Responsible Person (RP), supporting the worldwide virtual wholesale distribution operation and associate RP/GDP requirements for GSK's Consumer Trading Partner. You will also lead and develop Supply Chain Accounting and Trading Partner Finance Quality function to ensure that all Quality Systems and processes involved in the supply and distribution of product comply with internal and external regulations requirements, are effective and efficient. Moreover, you will develop our strategy associated with changes in the external regulatory environment.
Work closely with Global Head In-Country Quality to:
• Act as key support in activities and initiatives in line with changing external Regulatory requirements
• Perform all responsibilities as CH Quality SME in major change initiatives such as Brexit, collaborating with cross functional senior leaders to develop and drive the delivery of strategic plans
• Provision of expert Quality / Regulatory advice to other departments and teams within the company to support licencing set up in the EU and other territories.
• Proactively identify potential obstacles and manage the resolution of issues.
• Act as subject matter expert to mitigate regulatory compliance risk for Consumer Trading Partners
Partner with PTC Quality Manager on the following:
• Lead, manage and develop the quality organization in Supply Chain Accounting & Trading Partner Finance ensuring it is adequately resourced with appropriate skills and capability.
• Lead, use and maintain the Quality Management System within SCA/TPF including (but not limited to) the following key processes:
o Change Control
o Risk management
o Deviations and Root Cause Analysis
o LICs, PIRCs and Recalls
o Corrective Action Preventative Action
o Self inspection and Internal auditing
• Accountable for the SCA quality council process, ensuring that quality risks, issues and metrics are discussed at a leadership team level and that appropriate actions and escalations are taken.
• Ensure SCA/TPF alignment to key decisions and programs from including (but not limited to) the LOC QLT meeting/ Consumer Healthcare Quality Plan or equivalent.
• Lead QMS implementation and Quality Alert processes.
• Manage SCA/TPF audit responses related to Quality using the CARISMA database.
• Member of the SCA Risk Management board, ensuring that risks are raised, evaluated, and escalated where appropriate, and taking ownership of appropriate risks for the business.
• Lead the CAPA Process and ensure it complies with applicable GSK, GMP and other regulatory requirements
• Accountable for ensuring adequate corrective and preventative actions (CAPA) are developed for major or critical observations arising from any audit, and monitoring progress against these actions.
• Ensure changes with the potential to impact product quality, safety and efficacy are identified and managed in line with the appropriate change control and/or validation processes.
• Deliver training related to the Quality processes owned.
Wholesale Distribution of Finished Products and API:
• Manage authorized activities and ensure accuracy of quality of records: implement effective documentation process.
• Ensure initial and continuous training program is implemented and maintained
• Work with relevant teams to manage the Customer and Supplier qualification process.
• Manage the Audit Universe and Audit Schedule such that an appropriate number of self inspection and business monitoring inspections take place in the department.
• Lead the preparation and hosting of Business monitoring/ Regulatory audits and inspections.
• Maintain all other authorizations / licenses and registrations as required nationally and internationally for the trading partners to operate.
• Manage the Falsified Medicines Directive process.
• Act as Designated Person, responsible for Importation, Storage or Distribution Activities for API
EU Importation of Finished Products:
• Liaise with Consumer division (LOC's) to maintain license for imports of Cx products.
• Demonstrate the key capabilities, behaviours and values as set out in the GSK Leadership Profile for "Leading Others".
• Ensure quality function operates in compliance with ABAC procedures.
If this sounds like the right role for you, please make sure to apply before the 20th of December!
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Thank you for your interest in this opportunity.
• Third level qualification in scientific discipline or demonstrated equivalent level of knowledge.
• Good level of understanding of regulatory requirements for distribution of medicinal products
• Experience in Quality or regulatory environment in a Consumer Healthcare or Pharmaceutical business subject to medicinal regulation
• Experience in the application and improvement of Quality Management Systems e.g. Corrective & Preventative Action, Deviation Management, Risk Management
• Knowledge of the management of the following licenses and registrations: Wholesale Distribution Authorisation (Human) with the UK MHRA, Manufacturing Import Authorisation (MIA) with the UK MHRA, Falsified Medicines Directive registration with the UK MHRA, Controlled Drug Licence with the UK Home Office, Precursor Chemical Licence with the UK Home Office
• Science graduate or equivalent degree, or equivalent work experience
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires
You may apply for this position online by selecting the Apply now button.
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