Regional Quality Head Americas

4 weeks ago

Philadelphia, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: Philadelphia Walnut Street, Durham Blackwell Street
Posted Date: Aug

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 t o 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 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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