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Job Title: LOC Quality Lead and Responsible Person – Rx Slovenia
Reports to: CE Quality Cluster Lead / Job Creation Date:Business Level 1: Pharma EU Central Europe Cluster
Business Level 2: Pharma EU Regional LOC Quality
Business Level 3: EU & EMAP Pharma Supply Chain Quality
JOB PURPOSE :
The job exists within the commercial Rx Local Operating Companies to ensure that the mandated local and european GDP/cGMP regulations as well as GSK Quality Management Systems requirements for commercial operating units are met, securing therefore the wholesale license needed to allow the operations. The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance and shall take the relevant decisions to secure product integrity and patients safety. The job holder is expected to take the lead in implementing and sustaining the QMS in the country, including encouraging the Commercial Rx business to own quality activities in their day to day work.
KEY ACCOUNTABILITIES / RESPONSIBILITIES :
1. Quality Strategy
· Act as a Responsible Person of GlaxoSmithKline Slovenia according to Medicinal Products Act, Official Gazette 17/14 and Rules on the system for the receipt, storage and traceability of medicinal products, Official Gazette 82/15.
· As a Responsible Person, in line with EU and Local regulations, maintains a high level of QMS and local regulatory knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity with regards GDP activities.
· Key market contact and responsible person for all QMS activity and issues, relating to the commercial business.
· Assess and proactively create and implement a continuous improvement plan for the adoption of the principles and requirements of a Quality Management System into the commercial business, includes identifying, understanding and sharing appropriate information.
· Heighten and promote quality and QMS awareness in the commercial business functions.
· Engage and assist relevant stakeholders in understanding and generating appropriate systems, processes and policies, as required within defined areas of the business, in compliance with QMS principles.
· Build strong relationships across the LOC Commercial Business functions and work with them to develop quality objectives that meet both business and regional quality objectives. Undertake relevant training forums to deliver QMS knowledge to relevant parts of the business enabling them to identify, incorporate and deliver on relevant quality objectives.
· Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
· Develop a network to obtain local regulatory intelligence and provide the necessary analysis to understand and escalate issues which have the potential to impact supply or GSK’s reputation.
· Act as the relevant LOC quality contact for the Regional Quality organization providing communication to the regional quality organization on progress on QMS compliance status updates on quality plans and escalation of issues. Share learning’s and issues appropriately with other LOC and regional colleagues.
· Gain understanding of the high level business plans of the LOC as they potentially link to quality – ensure any quality activities are identified and defined in the annual quality plan.
2. Quality Systems
· Responsible for the ensuring a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the Slovenian Marketing Company.
· Responsible of the control and assurance of all processes for receipt, issuing and review of documentation relevant for medicines and medical devices in accordance with the Medicinal products Act and Rules on the system for the receipt, storage and traceability of medicinal products with 24/7 availability. Duties can be delegated when appropriate but the responsibility remains with the Responsible Person.
· Implement and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies , cGMP, GDP and regulatory requirements by performing the following:
o Ensure that all SOPs are in place, updated & training has been conducted across the business. Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance. Processes in place for delivering routine training for updates to SOPs, GQPs, GQMPs as relevant.
o Promote QMS management principles and seek continuous improvement of the processes, holds trainings on quality management
o Review, conduct impact assessments and implement any updates to QMS policies
o Manage QMS Management Review meetings according to local SOPs
o Identify, Implement and Manage QA Objectives & KPIs
o Establish and manage Annual Quality Plans
· Ensure that all internal procedures and systems in use in the LOC are compliant to GSK QMS, Guide for Commercial Companies and local regulatory requirements, including (but not limited to):
o LOC Quality Council in place with regular meetings and including all relevant business functions. LOC Quality Council format, frequency and reporting standardized to global requirements. Quality metrics and reporting format/ system in place with oversight and review during LOC Quality Council
o Change Control - Effective local change control process in place to manage all planned major changes (including new pack introduction, product discontinuation, major pack changes, re-packing activities). Change control process links to risk management process and risk assessments completed. Processes in place to routinely review progress of changes and close out when completed.
o Risk Management - Local risk management process in place across business with common review and escalation process. Local process in place to manage, report, review and escalate quality risks. Quality should be linked to the local Risk Management Board.
o Corrective and Preventative Actions (CAPA) - Implement global or local process to effectively manage corrective and preventative action plans. Develop local processes to conduct root cause analysis to investigate deviations and develop CAPA’s. Local process in place to track and review CAPA plans on routine basis. Demonstrate that LOC effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out.
o Auditing - Local process in place for Management Monitoring (Level 1 audit/self inspection, MM) and Internal auditing(Independent Business Monitoring, IBM) – includes clear accountability for sign off of audit reports and resultant CAPA/ Risk management. MM and IBM audit universe defined and agreed with Regional Quality or delegate (Cluster Quality) and annual audit schedules in place. Processes in place to ensure all new and existing suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality are identified and audited by QA team according to agreed audit schedule. e.g. distribution sites, repacking contractors, warehouses, freight management, samples supply, off-site archive sites, artwork printers, printed packaging component suppliers. Ensure LOC is audit ready for any relevant Level 3 or 4 audit. Responsible for Regulatory Inspection Management
o Complaints - Effective complaints management process in place with monthly reporting to consider trends and identify improvement opportunities. Complaints management process should also have clear link to adverse event reporting and be able to determine product quality issues as quickly as possible and link into local product incident process.
o Incident and recall management - Effective local product incident process in place to escalate and manage any product quality related issues. Must be well documented process and link into Quality Council as well as into above country PIRC process. All relevant staff trained in local incident management process and global PIRC process. Efficient recall measures are triggered when appropriate.
o Product supply – Develop, specify and approve systems that have an impact on the quality of imported, products in line with all relevant GQPs:
o Accountable that TTSs are in place to ensure compliance to local registered technical details.
o Maintaining and updating Quality agreements with local warehouse and MMW
o Liaison with External Supply Quality for products that are manufactured by contractors to ensure compliance to local registered technical details.
o Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries. More specifically: maintains the relevant licenses and authorizations, in line with European and local regulations, to allow storage and distribution of medicines in the Slovenian market, review quality of all incoming goods into the local warehouse, ensure timely local Quality release of imported finished goods deliveries from the MMW to the market or dispatched through the local LSP warehouses and finally to the market, resolve Quality-related issues arising from the above mentioned deliveries, ensure appropriate processes are in place for storage, including temperature monitoring and control during storage and transport, stock management (quarantined and rejected stocks, counterfeits) as well as withdrawal of medicinal products, archiving of all related warehousing GxP documents in line with GSK’s policies and local regulations, ensure an appropriate process for cutomer returns is in place and takes final decision on related batch disposal, ensure sufficient training is provided to wholesale personnel covering GDP/cGMP activities as well as counterfeits management
o Risk evaluation and control of suppliers and customers in line with EU GDP and local regulations
o Acts as the primary liaison with the GMS supplying sites, R&D and Regional Quality as it relates to approval of repacking activities and resolving Quality issues with the product supplied as well as DRA completion
o Artwork management - Oversee the effective implementation of Artwork Management procedures within the LOC.
o Oversee the effective implementation of Artwork Management procedures within the commercial teams
o Local Repacking - Manage all matters pertaining to regulatory and QA compliance for repacking procedures to ensure timely QA batch release of repacked orders before distribution and/or re-export. Ensure documentation of batch records and retention of samples.
o Ensures there is a process in place for the Management of Quality and Regulatory Intelligence for Regulatory Compliance (QRI) and Quality Alerts and Quality Bulletins
o Contact with Local Regulatory Agency: local contact in the country of the Local Regulatory Agency with regards counterfeits, rejects for products on the local market. Ensure stock shortages are reported to Regulatory agency in line with local and GSK requirements. Reports new product launch on the market and "sunset clause”
3. Management of quality team in LOC
· Manage and co-ordinate day to day quality department activities including resource allocation, workflow, project priorities and department initiatives.
· Manages and develops quality staff within LOC team to drive a quality culture within the LOC
Reporting Line:
1. Report dotted line to - NA
2. Report solid line to CE Quality Cluster Lead
KNOWLEDGE / EXPERIENCE / SKILLS / COMPETENCIES REQUIRED :
Education and Experience:
· Successful completion of relevant tertiary qualifications – science degree of Faculty of Pharmacy
· Minimum of 3 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a senior quality manager
· Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, repacking, artwork control and performing audits
· Strong knowledge of regulatory requirements pertaining to cGMP/GDP
· Good knowledge on effective quality documentation systems
Computing skills:
· Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
Language skills:
· Active command of English (written and verbal)
Competencies/Other skills:
· Professional written and verbal communication skills. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization.
· Ability to influence and motivate stakeholders at any level 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.
· Able to effectively enable and drive change across cross functional stakeholders.
Other requirement:
· Responsible Person has to be Slovenian citizen
JOB FACTORS
ACCOUNTABILITY:
Pharma Commercial operating business units, global QA and Global Logistics
- Developing, owning and deploying standard local processes in line with global QMS Policies with regards product quality in Hungarian Pharma commercial business
- Responsible Person in line with local Regulatory requirements
- As Responsible Person, Product Quality accountable for Slovenian Pharma Business and represented in Slovenian extended management team
- Technical expert within function, working with moderate supervision from Line Manager.
- Leads local quality projects.
- Line Management responsibility: subordinate: QA specialist
- Key role in ensuring overall quality targets are achieved for Pharma organization within agreed timelines .
- Reports to organizational level 1 of Pharma CE Cluster Quality
- Local QA budget responsibility
COMPLEXITY:
Quality responsibilities:
Interacts with Quality organizations as well commercial organizations, with potential variations in expectations, ways of working and in a highly changing environment. Strong flexibility and organizational skills are expected for this role.
Interpersonal skills:
Numerous interactions with non quality stakeholders for information sharing, escalation and problem solving but also improvements and implementation of changes. Strong influencing and communication skills in a heterogeneous organization are expected for this role. Externally interacts with Regulatores and influences customers, suppliers and vendors.
Solving issues:
The job operates in a defined environment where changes occur.
Identifies problems and implements solutions.
Diverging problems/ incomplete and uncertain information; a detailed analysis of the issue is necessary.
Acknowledged by : / Approved by :
Name : / Name :
Date : / Date :
Organization chart