Regional Quality Head Americas

Job Purpose:

This position is to 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 organisation and GSK regulatory affairs organisation.

Key Responsibilities:

• 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.

• Building strong relations with the health authorities; being the quality voice of GSK Global Supply Chain

Why you?

Basic Qualifications:

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

• Bachelor Degree in scientific or engineering discipline with 15+ years of relevant experience.  Degree in Biological, Biochemical, Pharmacy, Chemistry or other related education preferred.

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

• Experience and understanding of QMS and GDP, its application and business objectives

• Leadership experience

• 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

Preferred Qualifications:

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

• Master of Science or PhD in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge

• 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

• Proven experience in interacting with FDA on drug shortages, Field Alerts, BPDR’s is required.

#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 t