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Senior Compliance Director US Oncology

3 months ago

Philadelphia, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - Philadelphia
Posted Date: Aug 6 2024

Senior Compliance Director, Oncology Business Unit - US Pharma

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. Through the successful implementation of GSK Internal Control Framework and compliance programs, this role will Lead Compliance strategy to ensure that the right product gets to the right patient or population in the right way. Located at the Philadelphia Walnut Street location with onsite presence 2-3 days per week.

Specifically, the Compliance Director will be accountable for lead the strategic direction and oversee execution of US PH compliance within the Oncology Business Unit by:
  • Strategically driving improvements in the Oncology BU compliance program by keeping abreast of external developments and ensuring that programs are aligned with industry and regulator expectations (e.g., DOJ). Partner with cross-functional business leaders and compliance business partners to assess the continuous improvement needs in operational excellence of compliance programs.
  • As a key member of risk and governance forums, encourage discussion of relevant, significant risks and ensure that issues and conclusions are escalated upward. Active membership in Oncology BU governance meetings (e.g. Risk Management and Compliance Boards, project steering committees).
  • Coordinating the Risk Management and Compliance Board for the Oncology BU and provide summary of RMCB discussions and escalations to the US Pharma RMCB. Partner with the business to develop and oversee completion of CAPAs resulting from investigations, monitoring, audits, or inspections
  • Overseeing the development and coordinating the implementation of any required Oncology BU controls to ensure alignment with the Code of Conduct and GSK US PH policies.
  • Acting as a change leader for cutting edge practices and standardization, where appropriate, to simplify the complexity of our practices
  • Implementing compliance solutions by translating global requirements into local specifications, including any relevant training
  • Maintaining and informing leadership of the Oncology BU Key Risk Indicators by coordinating compliance data analysis, and reporting activities, to manage compliance program data trending and tracking, as well as enhanced performance reporting.
  • Promoting a Values-based culture through encouragement of, among other program elements, Speak Up
  • Ensuring adequate training and communication programs in place to guide people in conducting GSK business in risk areas
  • Ensuring risk management plans and actions are in place to achieve the objectives and follow up with risk owners / functional heads etc. to ensure delivery.
  • Identifying emerging risk areas for the Oncology BU through maintaining current Brand Risk Management Plans through awareness of current product specific risk areas as well as industry and cross-industry compliance trends and challenges.
  • Providing regular reports to VP, Compliance Officer US Pharma on the performance of controls and specific issues that arise.
  • Liaising with Legal and/or Business Leaders oversees investigations of all serious compliance matters together with the investigation team.
  • Liaising with HR Coordinates regarding disciplinary activities for standard violations to ensure uniformity and to determine need for additional educational efforts
  • Ensuring audit processes are in place for such activities and reviews audit results to determine remedial action if required. Tracks and reports on completion of management actions to address significant audit findings.
  • Facilitating the internal reporting processes to ensure that GSK employees and agents can report ethics and compliance concerns without fear of retaliation.
  • Implementing effective processes for the investigation of identified instances of noncompliance or misconduct. These should include directions regarding the prompt and proper response to detected offences, such as the initiation of appropriate corrective action and preventive measures and processes to report the offence to relevant authorities in appropriate circumstances.
  • Engaging with external parties to promote and defend GSK's industry ethical lead and shape the external environment


Core Deliverables and Outputs
  • Accountable for ensuring US PH compliance program is effective and fully implemented with the Oncology BU.
  • Accountable for implementation of updated Brand Risk Management Plans and relevant monitoring programs (e.g. Key Risk Indicators, Independent Business Monitoring) over Oncology BU significant risks.
  • Ensuring that GSK's compliance culture is embedded at all levels of the organization
  • Accountable for ensuring employees understand compliance requirements and use good judgment in activities and for ensuring appropriate monitoring and auditing to verify.
  • Establishes and maintains credibility and trust throughout the organization and is able and willing to consistently advocate disciplinary actions for compliance and ethics violations.


Accountability: Relationships, Networks and Core Stakeholders
  • Engages with leadership teams to shape and define business strategies, working to manage the interface of agendas and drivers between other relevant areas of GSK. Helps the Oncology BU to evaluate multiple strategic alternatives.
  • Shares best practices with peers in the industry through informal discussions and presentations at educational events.


Why You?

Basic Qualifications:
  • Bachelor's Degree in Life Sciences, Business, Law with minimum 10 years of pharmaceutical/medical device experience
  • 8+ years' experience in Compliance, Audit, Legal or Internal Controls role
  • 5+ years' experience in a matrix environment and with leadership in the application of innovative approaches with portfolio-level impact


Preferred Qualifications

Post-graduate Degree / Qualification - Life Sciences, Business, Law, Finance
  • 15 years of pharmaceutical/medical device experience
  • Extensive knowledge and insight into industry issues and regulations global markets and underlying reasons for current conditions.
  • Possesses organizational knowledge required for identifying areas of compliance vulnerability and aligning the compliance functions with the business
  • Extensive years in industry with several years of demonstrated leadership and influence
  • High degree of organizational awareness; demonstrated ability to develop solutions to complex problems
  • Maintain a high degree of credibility, independence, integrity, confidentiality, and trust.
  • Strong writing skills required to write and edit policies and procedures, issue memoranda and compile program reports.
  • Has a deep understanding of the GSK products, competitors
  • Exhibit strong analytical skills and an understanding of operational processes and technology concepts
  • A strong sense of initiative, urgency, drive, pragmatism, and judgement - an ability to make things happen.
  • Ability to deliver to demanding deadlines whilst maintaining the highest quality


#LI-GSK

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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