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 organization 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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Senior Quality Specialist – DNP markets

Senior Quality Specialist will support and follow the directives of the Associate Director

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

Quality Management System (QMS) – implementation and maintenance of an effective QMS to ensure that local operations are in full compliance with GMP and GDP and local regulatory requirements for markets supported by the operation, and GSK standards and policies

SOPs - SOP’s for QMS processes are in place, updated and training has been conducted to relevant functions. These processes include:

• Product release -review of transit temperature data prior to distributor release for sale

• Complaints –clear link to adverse event reporting and local product incident process for markets in scope of the operation

• Incidents management - manage according to local timelines and communicate any product quality related issues

• Recalls –oversee a market recall, enacted through the in-market distributor.

• Change control –manage all planned quality related changes including new product introduction, product discontinuation, major pack changes, re-packing activities. Review progress of changes and close out when completed.

• Deviation –investigate deviations and develop CAPAS’s

• Corrective and preventive action (CAPA) –manage corrective and preventive actions. Ensure that effectiveness check is performed for CAPA’s

• Imperfect deliveries / Distribution incidents –oversight of transportation damages, missing or non-conforming temperature data, and hidden quality defects from the distribution chain or manufacturing site

• Risk Management –manage and escalate quality risks

• Periodic Product Review –MAH responsibilities for Periodic Product Review requirements as per market requirements

• Auditing –management monitoring level 1 (self-inspection) and internal business monitoring level 2 auditing; new and existing GxP 3rd party contractors are identified, qualified and audited; the Hub is audit ready for any relevant internal audit

• Quality Council/Management Review – in place with regular meeting aligned with Partner Markets, including all relevant business functions.

•  Maintaining the Supply Agreement framework to support the supply of quality product

• Objectives and KPI’s – Identify, Implement and Manage QA Objectives & KPI’s.

• Quality Plans – Establish and manage Annual Quality Plans

Why you?

Qualifications:

• Relevant science-based degree or equivalent experience

• Professional experience 3 years+ in pharmaceutical industry

• Experience in quality assurance work within a company that manufactures medicinal products

• Understanding of manufacturing of medicinal products (GMP), or the wholesale of medicinal products (GDP)

• Language knowledge (Minimum fluent English plus one other)

• Technical understanding of QMS deployment

• Influencing skills

• Continuous improvement mindset

Why GSK?

What we offer:

• Career at one of the leading global healthcare companies

• Contract of employment

• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

• Life insurance and pension plan

• Private medical package with additional preventive healthcare services for employees and their eligible counterparts

• Sports card (Multisport)

• Possibilities of development within the role and company’s structure

• Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)

• Supportive community and integration events

• Modern office with creative rooms, fresh fruits everyday

• Free car and bike parking, locker rooms and showers

Inclusion & Diversity at GSK:

Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career. GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant. We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ([email protected]) to further discuss this today. We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application.

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity/Affirmative Action 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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