Quality Director, ViiV Supply Chain

Are you energized by a highly impactful operational compliance role that allows you to shape and accelerate regulatory quality and capability across the organization? If so, this Operational QA Director role could be an exciting opportunity to explore. 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 licences, This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• 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 (supply sites, quality service providers). This will involve working with the Quality or Compliance groups in the 3rd parties (GSK, Pfizer and others in the future)
• 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 either from the 3rd parties or from the ViiV Healthcare Supply Chain team
• Lead local and escalated product incident investigations to include chairing PIRCs and making recall recommendations to the Recall Board. Provide Quality oversight for ViiV Healthcare on PIRCs and LICs when managed by a 3rd Party (e.g. GSK).
• Manage the reporting and review of quality key performance indicators from ViiV Healthcare Supply Chain and 3rd parties relating to the supply chain activities for HIV products
• 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 (x= Distribution and Manufacturing)
• 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 These duties are documented in UK legislation.
  
  We are looking for professionals with these required skills to achieve our goals:
• Experience in leading pharmaceutical quality assurance and compliance, within a manufacturing/supply chain environment, working with a broad range of pharmaceutical products. Significant period working in an Operational Quality role.
• Experience of working with local operating companies/legal entities in deployment of Quality Management Systems and the setting up of quality agreements both within GSK and across third parties
• 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 delivering a business benefit and advantage
• Working knowledge of cGMPs, FDA guidelines and international guidelines dealing with pharmaceutical manufacturing/supply chain and quality assurance
• Experience in delivering training / coaching / project improvement programs in diverse cultural environments
• Knowledge of R&D quality processes.
• Knowledge of product and medical device registration processes, e.g. NDAs/BLAs and MAAs.
• General knowledge of regulatory compliance requirements.
• Demonstrated knowledge and experience in one or more specific pharmaceutical dose forms or technologies, manufacturing processes and / or regulatory submissions
Preferred Qualifications: If you have the following characteristics, it would be a plus:
• Knowledge of the HIV/ViiV product portfolio
  
  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. We do this by being a trusted partner for all people living with and affected by HIV.
We are aware of how much is at stake for those affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are eager to make a difference., At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV. We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK. Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to 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. Important notice to Employment businesses/ Agencies ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit ViiV's Transparency Reporting For the Record site.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK