Regional Quality Director - Americas

As a Regional Quality Director - Americas you will provide leadership and management support to the America’s LOC Quality (US, Canada, Central and South America) on in-market distribution to ensure compliance with GSK Quality Management System (QMS) and appropriate local regulations and align with business objectives.

The position holder is 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 required to develop LOC quality leaders to be highly effective in making quality and business critical decisions.  Including building strong relationships with the external authorities (including FDA, Anvisa, Health Canada), and internal partners GSK commercial organization and GSK regulatory affairs organization.

Key Responsibilities:

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:

• Bachelor’s degree in scientific or engineering discipline

• Experience in pharma industry (manufacturing, quality control, quality assurance, distribution)

• Experience working with QMS and GDP

• Experience with people leadership including direct report responsibilities

• Experience leading cross-site locations and cross functional teams

• Experienced auditor, able to conduct level 2 audits and provide auditor training for self-assessments

Preferred Qualifications:

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

• Master of Science or PhD in scientific or engineering discipline

• 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

• Able to work effectively in English

• Self-starter, able to schedule and progress workload on own

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

Why Us?

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 positively impact the health of 2.5 billion people by the end of 2030.

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