Reference #: 395733
Site Name: USA - Pennsylvania - Philadelphia
Posted Date: May 6 2024Senior Compliance Director, Oncology Business Unit - US PharmaGSK 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.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 pr mpt 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 environmentCore 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 demonstrated leadership in the application of innovative approaches with portfolio-level impactPreferred 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-GSKPlease visit to 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