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Director, Operational Quality

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GSK

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Location:
United States , Collegeville, Pennsylvania

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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

Nice to have:

  • 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
What we offer:
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes

Additional Information:

Job Posted:
March 01, 2026

Employment Type:
Fulltime
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