LOC Quality Manager

Job Description

Site Name: Morocco - Casablanca Posted Date: Oct 25 2022 Job Purpose The job exists within the commercial Rx Local Operating Companies to ensure that the mandated GSK Quality Management Systems requirements for commercial operating units are met. 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. The job holder is expected to take the lead in implementing and sustaining the QMS for GSK LOC, including encouraging the Commercial Rx business to own quality activities in their day to day work. Key Responsibilities Quality Strategy 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 organisation providing communication to the regional quality organisation 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. Quality Systems Responsible for ensuring a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within GSK LOC/Marketing Company. Implementation and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies, GMP, GDP, and regulatory requirements by performing the following: escalation of persistent non-compliance. Processes are in place for delivering routine training for updates to SOPs, GQPs, and GQMPs as relevant. Promote QMS management principles and seek continuous improvement of the processes Review, conduct impact assessments, and implement any updates to QMS policies Manage QMS Management Review meetings according to local SOPs Identify, implement, and manage QA Objectives & KPIs 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) LOC Quality Council is in place with regular meetings including all relevant business functions. LOC Quality Council format, frequency, and reporting is aligned with global requirements. Quality metrics and reporting format/ systemis in place with oversight and review during LOC Quality Council Change Control - Effective local change control process is 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. 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. 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. Auditing - Local process in place for Level 1 (self) and Level 2 auditing ? includes clear accountability for sign off of audit reports and resultant CAPA/ Risk management. Level 1 and Level 2 audit universe defined and agreed with Regional 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. 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. Report and follow up on product complaints with manufacturing sites, customers and commercial teams. Incident 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. Product supply - Develop, specify, and approve systems that have an impact on the quality of imported, products in line with all relevant GQPs: Accountable for review and approval of TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details. Liaison with External Supply Quality for products that are manufactured by contractors to ensure compliance to local registered technical details. Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries. 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 Artwork management - Oversee the effective implementation of Artwork Management procedures within the LOC. Oversee the effective implementation of Artwork Management procedures within the commercial teams Ensure that the commercial business units can effectively use the global pack management systems (GPM) for Artwork Management by acting as business deployment lead to relay GPM requirements and also to feedback the market needs to GPM 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. 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. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor?s Degree ( pharmacy/Pharm ) Minimum of 5-8 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a senior quality specialist or a manager Essential Skills and Abilities: Professional written and verbal communication skills. Able to deliver clear 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 People management and development skills 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 Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits Strong knowledge of regulatory requirements pertaining to GMP/GDP Good knowledge on effective quality documentation systems Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making ? using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness *This is a job description to aide in the job posting, but does not include all job evaluation details. GSK is a global biopharma company with a special purpose ? to unite science, technology and talent to get ahead of disease together ? so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns ? as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it?s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We?re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. Contact information: You may apply for this position online by selecting the Apply now button. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. 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