Basic qualifications: 

Profile:

Minimum Level of Education  B.S. degree in a relevant scientific, quality system or technical discipline or experience in (bio)pharmaceutical manufacturing and quality operations if sufficient technical and operational depth has been achieved from profressional experience.

Area of Specialisation Science (biology, chemistry, pharmacy) or engineering degree or other technical related field.

Job-Related Experience
•Experience in planning and executing pharmaceutical supplier audits to identify, manage, correct and reduce significant risks / non-compliances.
•Demonstrat ed experience in audit techniques, including listening and interviewing skills.
• Demonstrated project management experience leading a site/division supplier quality audit management process.
• Experience in negotiations and influencing improvement activity (especially in quality culture and GMP compliance) to ensure implementation of appropriate corrective / preventive actions, quality standards and quality agreements.
• Knowledge of regulatory and quality system requirements and ability to explain, influence and negotiate with supplier organizations to comply with standards.
• Excellent verbal and written communication in French and English to ensure issues, risks and opportunities are well understood by all parties and that effective actions are put in place.
• Experience with the application with operational excellence (Lean/Six Sigma) tools and techniques.
• Demonstrated ability to function effectively in a matrix organization in order to ensure effective use of resource and communication of issues to all impacted sites / functions.
• Experience with Microsoft Office applications and have the ability to learn new software applications such as SAP.

Other Job-Related Skills/Background
• Demonstrated ability to function effectively across multiple cultures and geographic boundaries.
• Knowledge of technologies used within the material supply base.
Knowledge of world-wide GMP regulatory requirements and standards.

Preferred qualifications: 

See basic qualifications

Details: 

Our Company:

GSK is a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare.
We have a significant global presence with commercial operations in more than 150 countries, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.
Research is vitally important to the success of our business, and we spent just £3.4 billion in 2013 in our search to develop new medicines, vaccines and innovative consumer products. We are one of the few healthcare companies researching medicines and vaccines for the World Health Organization’s three priority diseases - HIV/AIDS, tuberculosis and malaria.
Our Vaccines business is one of the largest in the world, producing paediatric and adult vaccines against a range of infectious diseases. In 2013, we distributed more than 860 million doses to 170 countries, of which over 80% were supplied to developing countries.
At GSK Vaccines, we employ over 12,000 people worldwide, including more than 8,000 at our global headquarters in Belgium. Almost a quarter of our staff work in research and clinical development, inventing new and innovative vaccines against some of the world’s most serious infections and diseases.  
For more information please visit www.gsk.com

The department:

Global Quality Assurance is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
QA Belgium manages all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. QA Belgium is responsible for the release of final products made in Belgium and at international sites.
Applicants should have a master’s degree in science or engineering. Experience in the pharmaceutical or biotechnology area is an asset. GSK will give you the opportunity to develop strong organisational skills in a challenging and complex project-driven environment.

Job Purpose

Implement Supplier Quality strategies, business initiatives and improvement plans that will ensure a robust supply pipeline within GSK Vaccines. Ensure GSK external third party suppliers of critical materials and services comply with GSK quality requirements, cGMP and regulatory expectations.  Ensure quality requirements are clearly defined and understood by the supplier, supplier compliance status is assessed and measured for continual improvement and non-conforming materials and services are corrected. This role involves interface with the supply base but also provides an “inward facing” contact with designated GSK site(s) to ensure effective management of supplier issues on the site.

Key Responsibilities
• Coordinate quality aspects of source changes with GSK sites and provide input to global sourcing decisions and supplier management strategies by providing supplier performance reviews, risk and compliance assessments for existing, proposed alternative or new suppliers.
• Perform supplier quality system audits and assess supplier capability to meet product requirement specifications.  Identify supplier quality system risks and areas for improvement to ensure actions are incorporated into supplier corrective and preventive action plans. Approve and drive supplier corrective and preventive action plans to completion and conclude supplier use recommendations including acceptance of results from supplier certificates. Manage supplier data systems associated with audit scheduling, preparation, reporting and CAPA tracking within GSK systems.
• Perform investigations into significant quality incidents at supplier sites to identify root cause(s) and appropriate corrective and preventative actions are implemented.  Communicate investigation conclusions, including identified technical, regulatory and quality risks to stakeholders to support site usage and business decisions regarding materials and services.
• Use defined tools, techniques, and processes to perform and/or support supplier performance measurement activities to improve compliance across the supply base.  Lead supplier Quality Improvement and Supplier Quality Review Meetings with critical suppliers to ensure quality improvement plans are implemented.  Communicate improvement opportunities and plans to stakeholders.
• Negotiate and implement Quality Agreements with suppliers, incorporate GSK product specification requirements, when applicable.
• Communicate supplier related issues to internal stakeholders through appropriate escalation processes to ensure stakeholders understand technical, regulatory and quality risks.
• Evaluate and facilitate supplier change notifications with GSK user sites to ensure appropriate review and change management activities are identified for implementation, including supplier commitments, if applicable. Manage critical changes by suppliers and serve as a liaison for supplier aspects of change control and escalate issues and delays as required.

• Support the development and maintenance of GSK Supplier Quality processes to ensure compliance to the GSK Quality Management System.
Remain current with industry trends and changes in the regulatory and external environment through established networks – to ensure that any issues likely to impact the supply base are well understood and communicated in order to avoid disruption to supply.

Our Offer: 

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.  GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish.  GSK is an equal opportunity employer.

Contact information: 

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