Quality Director, ViiV Supply Chain

Site Name: UK – London – New Oxford Street, USA - North Carolina - Durham
Posted Date: Oct 31 2024

Quality Director, ViiV Supply Chain

ViiV Healthcare is a global specialty HIV company, the only company that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly mission-driven in our unrelenting commitment to leave no person living with HIV behind.

As our Quality Director, ViiV Supply Chain you will be responsible for providing a Quality Management capability to the ViiV Healthcare Supply Chain organization. The primary purpose of the role is to provide quality management services that ensure that ViiV Healthcare is effective in supplying HIV medicines that are safe and effective and manufactured in accordance with their product licenses.

Key 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 3rd parties.
• Co-ordinate preparation for level 4 regulatory inspections and support to other ViiV Healthcare entities.
• Establish, manage and where appropriate perform the internal quality systems audits.
• Review and approve change controls impacting on products or operations.
• Lead local and escalated product incident investigations.
• Manage the reporting and review of quality key performance indicators.
• Liaise with clinical trials supply teams and R&D Quality teams.
• 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 our managed Third Party Suppliers.
• Act as QP, RP or RPi if named on a licence.

Basic Qualifications:

• Experience in leading pharmaceutical quality assurance and compliance.
• Experience of working with local operating companies/legal entities.
• Experience in working with third parties including manufacturing, distribution, commercial operating companies.
• Experience in leading functional teams within a matrix environment.
• Broad based knowledge and experience of the application of Quality Processes.
• Working knowledge of cGMPs, FDA guidelines and international guidelines.
• Experience in delivering training / coaching / project improvement programs.
• Knowledge of R&D quality processes.
• Knowledge of product and medical device registration processes.
• General knowledge of regulatory compliance requirements.
• Demonstrated knowledge and experience in one or more specific pharmaceutical dose forms or technologies.

Preferred Qualifications:

• Knowledge of the HIV/ViiV product portfolio.

Interested in Joining the Team?

Please apply via our online portal providing your CV and Cover Letter.

Closing Date: 13th October 2024

Hybrid working applies to this role, with ViiV expectation of 2-3 days per week onsite.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included.

Why Us?

At ViiV Healthcare, we will not rest until we leave no person living with HIV behind.

ViiV is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.