Quality Director, ViiV Supply Chain

GlaxoSmithKline - Durham, NC

Full-time - Senior

Hybrid - Durham, NC

5,001-10,000 employees

Chemical Manufacturing

About the position

The Quality Director for ViiV Supply Chain at ViiV Healthcare is a pivotal role focused on ensuring the quality management of HIV medicines throughout the supply chain. This position is responsible for developing and maintaining quality systems, overseeing compliance with regulatory standards, and leading quality assurance initiatives to ensure the safe and effective delivery of products. The role emphasizes collaboration with third-party suppliers and internal teams to uphold high-quality standards in the manufacturing and distribution of HIV treatments.

Responsibilities

• Lead quality systems capability development in the ViiV Healthcare Supply Chain.
• Process owner/support for the ViiV Healthcare Quality Council.
• Develop and maintain the Supply Chain Quality Management System.
• Lead development of and approve quality agreements between ViiV Healthcare and relevant third parties.
• Coordinate preparation for level 4 regulatory inspections and support to other ViiV Healthcare entities.
• Establish, manage and perform internal quality systems audits as appropriate.
• Review and approve change controls impacting products or operations from third parties or the ViiV Healthcare Supply Chain team.
• Lead local and escalated product incident investigations, including chairing PIRCs and making recall recommendations.
• Provide Quality oversight for ViiV Healthcare on PIRCs and LICs managed by a third party.
• Manage the reporting and review of quality key performance indicators from ViiV Healthcare Supply Chain and third parties.
• Liaise with clinical trials supply teams and R&D Quality teams to provide necessary quality systems support.
• Provide training and expertise on the Supply Chain quality systems and relevant GxPs.
• Act as point of contact for any New Product Introductions.
• Provide Quality support for managed Third Party Suppliers.
• Act as QP, RP or RPi if named on a licence.

Requirements

• Experience in leading pharmaceutical quality assurance and compliance within a manufacturing/supply chain environment.
• Significant experience in an Operational Quality role.
• Experience working with local operating companies/legal entities in deploying Quality Management Systems and setting up quality agreements.
• Experience working with third parties including manufacturing, distribution, and commercial operating companies.
• Experience leading functional teams within a matrix environment.
• Broad knowledge of Quality Processes delivering business benefits.
• Working knowledge of cGMPs, FDA guidelines, and international guidelines for pharmaceutical manufacturing/supply chain and quality assurance.
• Experience delivering training/coaching/project improvement programs in diverse cultural environments.
• Knowledge of R&D quality processes and product registration processes (e.g., NDAs/BLAs and MAAs).
• General knowledge of regulatory compliance requirements.

Nice-to-haves

• Knowledge of the HIV/ViiV product portfolio.

Benefits

• Competitive salary
• Annual bonus based on company performance
• Healthcare and wellbeing programmes
• Pension plan membership
• Shares and savings programme
• Hybrid working model with 2-3 days per week onsite