Dan Trimberger

Experience

1. VP Ethics, Quality and Risk (Quality and Compliance)

   Verastem Oncology

   Nov 2022 — Present

   Establish and refine the compliance program in accordance with developing industry guidance and trends, with a focus on business growth objectives, needs and risks. Ensure the compliance program is effectively integrated into the culture and business operations, with the capacity to scale rapidly• Continue to reinforce a culture of integrity and raise awareness of compliance as a collective responsibility of all company personnel through effective engagement, training, auditing, and monitoring• Provide strategic compliance advice to the business to ensure compliance with applicable U.S. laws and company policies, including federal and state antikickback and false claims laws, the federal Food Drug and Cosmetic Act (FDCA) laws, the PhRMA Code, state laws, federal and state transparency laws, and antitrust laws• Review corporate strategy and enterprise risk management to identify the potential for compliance risk and advise on the structure and build of a compliance organization to support the identified objectives and risks• Develop compliance training curriculum and conduct training targeted to specific departments, groups and/or activities• Monitor and report results of the compliance efforts and provide guidance for executive leadership on matters relating to compliance• Lead and continue to further develop a fit-for-purpose Quality Management System (deviation, CAPA, change management, document control and training) to support both development and commercial operations. Lead the transition from a paper-based QMS to an electronic platform. • Lead preparations for and manage preapproval and routine regulatory agency inspections.• Assess GXP compliance risk and develop and implement risk mitigation plan(s)• Provide guidance, interpretation and information on GXP regulations, standards and quality systems• Accountable for the QA review of documentation submitted to regulatory agencies

Skills

• Quality Assurance
• Biotechnology
• Validation
• 21 Cfr Part 11
• Problem Solving
• Continuous Improvement
• Supply Chain Management
• Gxp
• Glp
• Auditing
• Change Management
• Change Control
• Quality System
• Quality Systems
• V&V
• Pharmaceutical Industry
• Sop
• Quality Management
• Gmp
• Capa
• Documentation
• Gcp
• Pharmaceuticals
• Cgmp