Director, Third Party Quality

EngineeringUK; London; On-site; GBP 150,000 - 200,000; Full time

Job description

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Site Name: Collegeville TSA, UK - London
Posted Date: Mar

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 Director, Third Party Quality, you will be responsible for the quality leadership of third party contract operations, 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 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. 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.
• 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 and 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, behaviours, and strategies.

Why you?

Basic Qualifications:

• Bachelor's Degree & 10+ years of pharmaceutical industry experience, including 2+ years of people management experience.
• Experience in at least one of the areas of Quality Assurance/Operations OR Production OR Engineering.
• Project management experience.

Preferred Qualifications:

• Master's degree.
• Knowledge of world-wide good manufacturing practices, regulatory requirements, and standards.
• Knowledge of the pharmaceutical industry's current best practice in analytical and manufacturing 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.