Director, Operational Quality

Role Summary

Location: Upper Providence, Pennsylvania, USA.

Drive the development, deployment, and sustainability of the quality management system for the manufacture and supply of products from a contract network. Lead quality leadership of third-party contract operations for large and small molecules, ensuring cGMP compliance for Drug Substance and Drug Product and supporting new business development.

Responsibilities

• Provide leadership for securing new products from business partners in GSK and outside GSK
• Manage development and performance objectives while coaching, mentoring, and providing feedback to a team of Quality professionals
• Establish clear accountabilities regarding product quality, employee safety, 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 regulators on scientific and technical matters which impact GSK and ensure that regulatory intelligence is collated, analyzed, and distributed for local action plans
• Lead site GMP compliance activities including self-inspection, internal audit, compliance metrics, QMS implementation, Quality Regulatory Intelligence, Quality Risk Model, DEA compliance, and CAPA verification
• Embed industry manufacturing tools and techniques to identify, manage, and escalate problems and develop solutions
• Mobilize and coordinate appropriate resources to address any significant product quality or regulatory incident
• Work with direct and indirect multi-functional teams within the region and the wider GSK global team
• Influence and build good relationships with internal and external stakeholders under contractual requirements
• Develop the capability of staff, including understanding regulatory changes
• Promote early visibility of regulatory issues and provide appropriate GSK response and position
• Foster teamwork and promote GSK values, behaviors, and strategies

Qualifications

• Required: Bachelor’s Degree
• Required: 7+ years of pharmaceutical industry experience
• Required: Experience in at least one of the areas of Quality Assurance/Operations, Production, or Engineering
• Required: Project management experience
• Required: Team leadership experience
• Preferred: Master’s degree
• Preferred: Knowledge of worldwide good manufacturing practices, regulatory requirements, and standards
• Preferred: Knowledge of the pharmaceutical industry’s current best practice in manufacturing and analytical technologies, engineering practices, validation and good manufacturing practice compliance
• Preferred: Experience with Contract Manufacturers
• Preferred: Demonstrate initiative analytical problem-solving skills
• Preferred: Ability to use and interpret data to drive decision making at both a tactical and strategic level
• Preferred: Ability to be flexible, adaptable, and a strong team player

Skills

• Quality leadership
• Regulatory inspections support and response writing
• Regulatory intelligence gathering and action planning
• GMP/QMS governance and CAPA management
• Quality risk management and DEA compliance
• Cross-functional collaboration and stakeholder management
• Analytical problem solving and data-driven decision making
• Continuous improvement mindset and industry best practices

Education

• Bachelor’s Degree (required)
• Master’s degree (preferred)