ViiV Healthcare (GSK) Operational Quality and Training Director

ViiV Healthcare is a global specialty HIV company, the only one 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 being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on and treatment for HIV.  We go to extraordinary lengths to deliver the sorts of breakthroughs, both in treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care.  We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic.

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 hungry to make a difference.

While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities.

ViiV Healthcare was created as a joint venture by Pfizer and GlaxoSmithKline in November 2009 with both companies transferring their HIV assets to the new company. In 2012 Shionogi joined the company. 76.5% of the company is now owned by GlaxoSmithKline, 13.5% by Pfizer and 10% by Shionogi.

As the Operational Quality and Training Director, you will be responsible for delivering Operational Quality for ViiV R&D and Training Oversight and Management to ViiV as the single point of accountability for ViiV Clinical Development. Ensures delivery of a consistent, uniform and effective management monitoring programme that provides assurance that clinical trial activities governed by GCP and related regulations undertaken by ViiV are compliant with ViiV policies / procedures and are conducted in accordance with accepted principles for clinical trial research. Responsible for ensuring the agreed compliance training strategy is in place, in use and effective in ViiV working across RDGM functions to deploy standard business processes and drive improvements in compliance learning whilst ensuring the organization meets regulatory requirements and most importantly delivers improved levels of competency and compliance.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

Operational Quality

• Define strategy and methodology for risk-based (define which risk criteria) Management Monitoring (MM); create annual MM plan to ensure inspection readiness, review periodically the outcomes of MM; escalate to appropriate governance and adapt the MM strategy accordingly
• Provide oversight of VH CAPAs to completion including ensuring all CAPAs have current, relevant owners assigned and engaged and that CAPA owners are clear on their accountabilities.
• Provide oversight of Management Monitoring (MM) of CAPA actions including the provision of effectiveness checks, where appropriate
• Provide RDGM LT with reports of CAPA completion data (late, near due, due later) including at risk CAPAs
• Support preparation activities and the management of Regulatory Inspections for Development programmes
• Lead Root Cause Analysis for MM or VH GCP Audits
• Maintain contemporary knowledge in the evolving regulatory expectations.

Training

Accountable for the design, implementation and maintenance of the RDGM curricula

• Responsible for annual RDGM curriculum review
• Responsible for ad-hoc curriculum revisions (addition or retirement of courses and/or curriculum creation)
• Responsible for the authorship, co-authorship, course creation, revision and/or retirement for >90% of courses

RDGM single point of contact for training and SOPs

• Liaise with GSK myLearning team to ensure proper identification and application of GSK training and ensuring relevance and applicability of