As the Americas Regional Quality Head, you are accountable to maintain an effective management oversight on LOC Quality through having in place an effective QMS and a competent LOC Quality team to support GSK Supply Chain and Commercial business. Strong leadership and knowledge are required to develop LOC quality leaders to be highly effective in making quality and business critical decision, including building strong relationships with the external authorities (including FDA, Public Health Agency of Canada, ANVISA), and internal partners GSK commercial organization and GSK regulatory affairs organization.

This position is to provide leadership and management support to the America LOC Quality (US, Canada, LATAM (-12 markets) on in-market distribution to ensure compliance with GSK Quality Management System (QMS) and appropriate local regulations and align with business objectives.

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

• Develop and monitor implementation of the quality strategy, quality plan and quality performance measures to support GSK business and drive quality improvement.
• Maintain an effective oversight of LOC Quality operations to ensure GxP licenses are maintained, LOC inspection readiness, quality critical matters are in control; compliance and regulations are timely and appropriate managed and resolved. 
• Ensure an effective management review and local governance.
• Strengthen the business partnership with commercial and Supply Chain operations.
• Build strong capabilities locally and ensure global awareness of Regional regulations.
• Ensure there is adequate and competent quality resource to perform the defined scope of LOC Quality operations in compliance with GSK QMS and appropriate local regulations.
• Enable right first time (RFT) launch through proactive collaboration between Quality Assurance/ Regulatory Affairs/ Supply Chain and ensuring compliance to local regulations.
• Embed Quality Culture and agile ways of working.
• Ensure clear accountabilities and teamwork across local and global functions.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelors degree
• 10+ years experience within Quality in pharmaceutical industry (manufacturing, quality control, quality assurance, distribution)
• Solid experience in interactions with FDA and other key regulators in the region (ie Public Health Agency of Canada, ANVISA)
• Experience and understanding of QMS and GDP, its application and business objectives
• Experience with commercial/post marketed products

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• BA/BS in Pharmaceutical science, Biomedical or Chemical engineering or Science
• Master's or PhD in Science or Engineering
• Exceptional leadership skills
• Excellent oral and written communication skills
• Proven influence and impact skills across business levels and functions
• Strong interpersonal and negotiation skills
• Problem identification and solving skills
• Competent people manager and able to identify and promote talent
• Ability to enable and drive change
• Self-starter, able to schedule and progress workload on own
• Experience of working with and leading cross-site and multi-functional teams
• Experienced auditor, able to conduct level 2 audits and provide auditor training for self-assessements
• Fluency in English both written and spoken

#LI-GSK

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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 t