Director, Third Party Quality

Are you looking for an opportunity to drive the development, deployment, and sustainability of the quality management system for the manufacture and supply of products from a contract network? If so, this is the role for you.

As the Director, Third Party Quality, you will be responsible for the quality leadership of third party contract operations, including new business developments, while supporting the performance of third party contract manufacturing companies over which GSK does not have direct control.  This includes providing quality operational oversight for the site’s compliance with current Good Manufacturing Practices (GMP).

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

• Provide leadership for securing new products from business partners in GSK and outside GSK
• Manage development and performance objectives while providing coaching, mentoring, and feedback on a regular basis
• Establish clear accountabilities regarding product quality, employee safety, Good Manufacturing Practices (GMP) compliance, OSHA compliance, and consistently achieving production schedules to meet market demand
• Guide, support, train and assess third party sites in regulatory inspections, including response writing.
• Support the efforts to positively influence regulators on scientific and technical matters which impact GSK and ensure that regulatory intelligence is promptly collated, analyzed, and distributed for incorporation in local action plans
• Lead site GMP compliance activities including but not limited to self-inspection, internal audit, compliance metrics, Quality Management Systems (QMS) implementation, Quality Regulatory Intelligence, Quality Risk Model, Drug Enforcement Administration (DEA) compliance, and Corrective and Preventive Actions (CAPA) verification
• Embed industry manufacturing tools and techniques to identify, manage, and escalate problems and develop solutions
• Mobilize and co-ordinate appropriate resources to address any significant product quality or regulatory incident
• Achieve objectives and work with a direct and indirect multi-functional team of Commercial, Business development, Regulatory, Technical and Supply within the region and the wider GSK global team
• Influence, build good relationships with key individuals, internally and externally, with pressure and recourse to contractual requirements
• Develop the capability of staff, including the understanding of regulatory changes
• Promote early visibility of regulatory issues providing appropriate GSK response and position
• Foster teamwork and promote GSK values, behaviours, and strategies

Why you?

Basic Qualifications:

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

• Bachelor’s Degree & 10+ years of pharmaceutical industry, including 2+ years of people management experience
• Experience in at least one of the areas of Quality Assurance/Operations OR Production OR Engineering
• Project management experience

Preferred Qualifications:

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

• Master’s degree
• Knowledge of world-wide good manufacturing practices, regulatory requirements, and standards
• Knowledge of the pharmaceutical industry’s current best practice in analytical and manufacturing technologies, engineering practices, validation and good manufacturing practice compliance
• Experience with Contract Manufacturers
• Demonstrate initiative analytical problem-solving skills
• Ability to use and interpret data to drive decision making at both a tactical and strategic level
• Ability to be flexible, adaptable, and a strong team player

#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 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.

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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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