Quality Manager, QMS Compliance

Basic qualifications: 

• Experience within the Pharmaceutical / Consumer Healthcare Industries, preferably in the capacity of a quality specialist or a manager.
• In depth Knowledge of regulatory requirements pertaining to GMP/GDP.
• Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits.
• Knowledge on effective quality documentation systems.

Preferred qualifications: 

• Ability to influence and motivate stakeholders at any level and function of the LOC organization
• Analytical mind, good attention to detail and problem solving skills within a structured process
• Good team player – works well in cross-functional teams
• Good time management skills, with ability to multi-task and work under pressure
• Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized.
• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
• Flexible thinking – able to challenge and see views from different perspectives
• Ability to self-motivate and be resilient and focused under pressure
• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook

Details: 

GlaxoSmithKline (GSK) is a science-led, global healthcare company that researches and develops innovative products. GSK currently employ over 100,000 people globally and has offices in more than 115 countries. Group revenues for FY2015 were £24 billion.
Most importantly, we help patients and consumers do more, feel better and live longer. What could be better than that?
GSK’s Consumer Healthcare Local Operating Company (LOC) Quality organisation plays a vital role in ensuring that quality products are manufactured and supplied to patients and consumers across the world. The LOC Quality organisation is part of the GSK Global Manufacturing and Supply organisation and employs over 200 Quality professionals across Europe, the Americas, Asia, Middle East and Africa, who support over 100 LOCs worldwide.  
GSK Consumer Healthcare was formed in March 2015 following the joint venture between GSK and Novartis Consumer Health.
What our employees say about us:
“We operate at the front end of the supply chain, ensuring quality oversight of the manufacturing and supply operation to enable quality products to be provided to our consumers and patients, and offering a fantastic breadth of experience of quality in a commercial environment.”
“Quality is a relatively new function within the new GSK Consumer Healthcare business and offers a great opportunity for shaping the Quality culture within a commercial environment”.
Meet Teri, Head of GSK Consumer Healthcare Quality
https://www.youtube.com/watch?v=BB54isUBKOk

•job title – Quality Manager QMS Compliance
•location - Brentford, Middlesex, UK
•competitive salary with benefits
•closing date for applications: 9th November 2016



What we’re looking for:
We are looking to attract a talented QMS Compliance Manager to work within the GSK Consumer Healthcare GB&I (Great Britain & Ireland) LOC. This role will work closely with other functions to ensure we have a quality management system which is in place, in use and effective in ensuring product quality, regulatory compliance and facilitating continuous improvement. We are implementing and embedding the processes, systems and culture to ensure we have an excellent foundation of quality and compliance which can support the business objectives. We therefore need someone who has the vision to shape the future and the ability to drive change within the organisation.

About this exciting role:
The position of QMS Compliance Manager within the GB&I LOC is a key role for the ensuring GSKs standards and requirements are embedded through a coherent system of operational processes within the LOC. We are in the process of implementing new systems and processes for quality and compliance related activities within the LOC and there is a great opportunity to influence and implement these new systems and processes. Reporting directly to the LOC Quality Lead, GB&I/Northern Europe, the position will ensure the GSK QMS is implemented to ensure an effective, efficient and compliant operation that facilitates continuous improvement and a right first time culture. 
The role will require building strong partnerships with Commercial, Regulatory, Supply Chain, Medical and Consumer Relations functions within the LOC, as well as with peers across Northern Europe and other Quality personnel.
Job Purpose: 
• The job exists within the Consumer Healthcare commercial Local Operating Companies (LOC) to ensure that the mandated GSK Quality Management Systems requirements for the Great Britain and Ireland commercial operating unit is in place, in use and effective.
• The role is critical to the effective management of processes and activities that have a direct impact to product quality and regulatory compliance or facilitate continuous improvement. The job holder is expected to take the lead in implementing and sustaining the QMS within the Consumer Healthcare Great Britain and Ireland LOC cluster. 
• As the QMS Champion, build and maintain strong partnerships with all functions to support implementation and roll out of the QMS, including but not limited to regulatory, medical, compliance, legal, supply chain (including customer services), marketing, and commercial such that Quality is seen as ‘everyone’s responsibility’.
• Ensure the QMS is fit for purpose in assuring product quality and regulatory compliance and driving business improvement within a commercial operating environment.
• Champion the use of key quality processes across the LOC such as change control, deviation management, including root cause analysis and CAPA. 
• Support the development of a right first time and continuous improvement quality culture built upon strong QMS foundations.

Key responsibilities:
Implement and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, GMP, GDP and regulatory requirements by performing the following:
• Actively measure, monitor, report and act upon KPIs related to the effectiveness of the QMS. Ensure KPIs are embedded within the LOC, including through the Quality Council process. 
• Support the development and implementation of local Quality Plans.
• Champion the use of the QMS within the LOC to ensure it is in place, in use and effective in all areas where there is a potential impact on product quality, regulatory compliance, and facilitates continuous improvement.
• Review, and implement processes that meet GSK QMS requirements, including (but not limited to):
• QMS Implementation – ensure GSK QMS requirements are systematically evaluated and implemented into the local Quality System and the overall effectiveness of the QMS periodically reviewed.
• LOC Quality Council – ensure effective meetings and framework in place to critically review quality performance, drive improvement and build quality awareness and accountability across the business.
• Change Control - manage all planned major GxP changes (including new pack introduction, product discontinuation, major pack changes, re-packing activities) to identify and mitigate potential risks and ensure successful implementation. 
• Risk Management – facilitate local quality risk management process and the interface with the LOC Risk Management Board such that risks are escalated and robust mitigation plans developed and implemented. 
• Incident management (LIC and PIRC) - effective local incident committee (LIC) process in place to escalate (to global Product Incident Review Committee (PIRC)) and manage any product quality related issues. 
• Quality Complaints - Effective complaints management process in place with monthly reporting to consider trends and identify improvement opportunities. Complaints management process should effectively interface with consumer relations, adverse event reporting and local product incident processes. 
• Corrective and Preventive Actions (CAPA) (including RCA and deviations) - conduct root cause analysis to investigate GxP deviations and develop robust CAPAs to prevent recurrence/occurrence. 
• Auditing – ensure local risk based audit schedule is in place and implemented and that audits and inspections, including Health Authorities Inspections are effectively managed and reported. 
• Manage processes to ensure that quality alerts and regulatory intelligence are evaluated and any actions planned and implemented.
• Manage local training and document control processes.

Please apply for this role using the online application system.  

*LI-GSK

Contact information: 

You may apply for this position online by selecting the Apply now button.