Director, Operational Quality

GSK•Upper Providence Township, PA

About The Position

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

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 Haves

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

Responsibilities

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