Doug Butler Email & Phone Number

Raleigh-Durham, North Carolina Area

As a contract position for USDM, I led projects supporting a risk management framework for Biogen, specifically for GMP-related risks. The project was initiated following an inspectional observation and resulted in a wholesale revisit by the Company to its risk management approach across pan-GMP risks. I facilitated over 40 individual risk workshops, compiled and documented risks, formatted these into a formal risk register, and was pivotal to setting up an escalation process for the most significant risks to senior management and established committees.

Led a global team of twenty individuals that provided internal controls assurance to senior management and the Audit Committee for risks related to global R&D operations (i.e., across Pharmaceuticals, Vaccines, and Consumer Healthcare, as well as 150 separate local operating companies globally). Surveyed and diagnosed the overall risk environment for R&D – spanning from early discovery through to post-marketing drug safety – and provided insight to senior management on the general state of internal controls and overall risk management. Negotiated solutions with business leaders when developing corrective and preventative actions, while simultaneously identifying efficiency opportunities to improve business operations. - Transformed the R&D internal audit approach from what had historically been an exclusively regulatory compliance focus (generally performed at an investigator site or individual study level), broadening the strategic focus to a fully risk-based approach, opining on risks at a pan-therapeutic or global level, including analysis and providing context for associated regulatory, reputational, and operational risks. - Partnered with peers responsible for internal audit of other complementary risk areas to identify and address risks that crossed disciplines in order to deliver more holistic audit coverage. (e.g., Product Quality Complaints, which includes a manufacturing risk element as well as an R&D risk element).- Partnered with business leaders to identify areas of emerging risk that would benefit from an independent review to strengthen internal controls. Engaged tailored reviews to identify business operations improvement opportunities, which included elimination of wasteful or duplicative steps and simplification of processes while simultaneously increasing individual accountability and strengthening internal controls.

Rtp

Formed and led a new team to facilitate better connectivity and communication between clinical therapeutic areas across GSK’s global R&D operations.- Developed and chaired a new clinical quality council forum, which brought together senior leaders from across GSK R&D to share insights, challenges, and solutions to clinical trial delivery.- Aggregated data and analyzed trends to create reports highlighting quality metrics. Presented and defended summary reports to internal compliance boards and senior management.- Led efforts to streamline internal processes, including an internal organizational reorganization for GQC, and full review and streamlining of Departmental SOPs, processes, and reporting mechanisms.

Rtp

Led a team of professionals performing internal audits of GSK’s global pharmacovigilance practices.- Led the implementation of a new and bespoke internal audit program for GSK’s pharmacovigilance system to assess the Company’s compliance with regulatory expectations and robustness of its adverse event reporting systems worldwide. Team implementation was acknowledged as a best practice solution by the MHRA Regulatory body during a routine inspection.- Consulted and negotiated with auditees to determine value-add solutions to control weaknesses identified during audit fieldwork, including both Regulatory-facing and non-Regulatory facing (e.g., business operations improvement) recommendations.

Masters, Accountancy

BSBA in Business Administration; Masters of Accountancy.

Bsba