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Director, Operational Quality New!


United States

United States || 2 Day Ago


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United States

Category :Vacant
Country :United States
publish date :2026-02-25
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Description


Site Name: USA - Pennsylvania - Upper Providence Posted Date: Feb 24 2026 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 [email protected] 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. Important notice to Employment businesses/ Agencies 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. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

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