Director, Operational Quality

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance.

Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

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 Third Party Quality Director, you will be responsible for the quality leadership of third party contract operations of both Large and Small Molecule, 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 of Drug Substance and/or Drug Product for the site's compliance with current Good Manufacturing Practices (cGMP).

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 to a team of Quality professionals.
• Establish clear accountabilities regarding product quality, employee safety, Clinical Good Manufacturing Practices (cGMP) 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, behaviors, and strategies

Why You?

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's Degree
• 7+ years of pharmaceutical industry experience
• Experience in at least one of the areas of Quality Assurance/Operations, Production, or Engineering
• Project management experience
• Team leadership experience

Preferred Qualification

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 manufacturing and analytical 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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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