ViiV Healthcare (GSK) Director, Compliance

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.

The Compliance Directo r will be an integral part of the North America Compliance team to embed the ViiV Internal Control Framework within the US LOC.

The Compliance Director will have a critical role, partnering with business leaders to reinforce and role model the highest standards of ethical behavior while providing expertise, consultation and assessments in matters related to compliance, ethics and risk.

The NA Compliance Director will proactively drive a culture of compliant, ethical and sound decision-making within the US business.

This role will report to the Senior Director, Compliance, NA.

The Director, Compliance will be based out of ViiV's US Headquarters in Durham, NC (Wake Forest / Chapel Hill / Raleigh / Cary area) & is eligible for a domestic relocation package.

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

• Effectively partner with business stakeholders by providing clear and pragmatic advice to assess risk in early concept discussions, align on actionable solutions to effectively mitigate risk upon implementation and evaluate effectiveness of risk mitigation activities, liaising with Legal, Finance and other partners
• As a key member of risk and governance forums (e.g., Speaker Programs Oversight, Transparency Core Decision Team, Registration & Licensing Team), proactively discuss risks, align on mitigation actions, ensure that issues and conclusions are escalated upward to ensure compliance with federal and state requirements
• Develop trusted relationships with employees of all levels to promote a SpeakUp culture and collaborate with teams to strengthen our values-based culture towards ethical decision-making
• Partner with business owners to develop and oversee completion of CAPAs resulting from investigations, monitoring, audits or inspections
• Proactively monitor evolving US healthcare environment, enforcement trends and emerging risks areas to identify and share insights
• Support coordination of the North America Leadership Team Risk Management & Compliance Board (RMCB)
• Drive improvements & operational excellence of the compliance program by keeping abreast of external developments and ensuring that the program is aligned with industry and regulator expectations (e.g., OIG, DOJ, PhRMA)
• Proactively identify opportunities for cutting edge, innovative solutions to simplify and optimize the compliance program
• Stay abreast of industry best practices & regulatory changes
• Develop and coordinate implementation of any required controls to ensure alignment with the Code and ViiV policies
• Ensure ViiV deploys policies and standards in a consistent and timely fashion utilizing the Internal Control Framework as appropriate
• Lead compliance program data analysis (e.g., Key Risk Indicators) and reporting activities to identify trends and proactively mitigate key and / or emerging risks
• Drive continuous improvement in policy training, shifting from training assignment and reminders to engaging, story-based content that enhances understanding and retention
• Lead investigation of identified instances of noncompliance or misconduct. Liaise with Legal, HR and other stakeholders as needed to coordinate corrective / disciplinary action

Basic Qualifications :

• Bachelor's degree & 6 plus years of experience in life sciences (pharmaceutical OR medical device OR biotech) compliance OR consulting
• 3 plus leadership experience

Preferred Qualifications :

• Bachelor's degree in Life Sciences OR Business OR Finance / Accounting OR Law
• Post-graduate degree in Life Sciences discipline, Business, Finance / Accounting, Law or a related field with applicable experience
• Demonstrated knowledge & understanding of US healthcare compliance and regulatory landscape : HHS OIG’s Compliance program guidance, US Sentencing Guidelines, Anti-Kickback Statute, False Claims Act, Federal & State transparency laws, PhRMA code Expert knowledge in HIPAA, State Privacy laws (e.g., CPRA,), etc.
• Expert knowledge of compliance issues related to payor relationships, distribution, coverage and reimbursement, patient access and Hub services
• Exhibit strong analytical skills and an understanding of operational processes
• Knowledge of emerging technology concepts (e.g., Artificial Intelligence, including machine learning and relevant frameworks, tools, platforms)
• Collaborative nature that can successfully align cross-functional stakeholders within a matrix organization through influence
• Learning through experience Demonstrates curiosity and learns from the experience of
• Ability to manage multiple competing priorities with excellent organizational and problem-solving skills.
• Excellent verbal and written communication skills; can present complex information in a clear, concise manner to cross-functional stakeholders
• Maintain a high degree of credibility, independence, integrity, confidentiality and trust.
• Acts with a strong sense of initiative, urgency, drive, pragmatism and judgement to follow through and complete projects in a professional and expeditious manner an ability to make things happen
• Proven ability to drive process improvement in a matrix environment and with demonstrated leadership in the application of innovative approaches
• Ability to deliver to demanding deadlines whilst maintaining the highest quality
• Ability to work in a fast-paced environment while demonstrating flexibility, commitment to teamwork, and a willingness to adapt assignments to meet business needs

LI-ViiV