Jon Dellaquila Email & Phone Number

Wilmington, Delaware

● Provide strategic direction for the U.S. Compliance function● Partner with U.S. Business functions to integrate compliance controls into existing business practices● Chair the U.S. Compliance Committee● Conduct compliance investigations related to potential violations of policies and regulations● Provide compliance training to U.S. Business Functions ● Develop and revise policies and SOPs to comply with applicable laws, regulations, and industry codes● Manage compliance monitoring function for the U.S. Business

● Serve as primary compliance contact for Specialty Pharma sales and Marking● Lead and conduct compliance investigations in response to alleged violations of rules, regulations, policies, procedures and the Code of Conduct in partnership with Legal and Human Resources● Develop and deliver compliance training and communications● Perform compliance monitoring on high-risk areas● Responsible for the development and management of Corporate Compliance policies and procedures

● Provide oversight to Impax's Specialty Pharma Division to ensure the Company's sales and marketing activities comply with applicable laws, regulations, and Company policies ● Develop and deliver Compliance training ● Create and revise Corporate Compliance policies● Analyze data to identify and prevent potential Compliance issues● Partner with Commercial, Legal, and HR leadership to invesigate and address compliance issues

● Develop, implement, and manage global compliance monitoring programs for the Commercial and R&D organizations● Conduct field based monitoring activities (e.g., routine sales call assessments)● Perform record reviews of high-risk activities (e.g., payments to HCPs, advisory boards, grants)● Conduct on-site monitoring assessment of international local operating companies● Create tools and templates to facilitate aggregate results reporting and identify trends● Proactively identify potential compliance risks using data analytic tools● Develop reports to communicate results to senior management● Collaborate with compliance business partners and business unit leads to implement remediation activities resulting from compliance monitoring assessments● Perform compliance investigations using investigative interviewing and data mining techniques● Oversee the global compliance helpline and case management system

● Improved internal controls by implementing new and revised policies and procedures, and providing compliance support in the development of R&D systems● Provided guidance and compliance support to R&D with a focus on interactions with HCPs● Directed activities of personnel supporting healthcare compliance activities● Collaborated with key stakeholders to implement strategic compliance objectives and resolve compliance issues● Assisted in the design and delivery of healthcare compliance training● Managed contract staff and external service providers

● Led global cross-functional teams to develop and revise company policies and procedures● Provided strategic input, guidance, and oversight to the R&D Quality Management System (QMS) and Learning Management System (LMS) teams● Developed role-specific training curriculum for the department● Performed process audits in conjunction with R&D Quality Assurance

● Evaluated clients' QMS to identify potential compliance risks and streamline processes for efficiency● Managed a core team responsible for developing, revising, and implementing procedural documents● Ensured client expectations were met by managing deliverables, timelines, and adherence to project budget● Developed and implemented quality monitoring service offering

● Utilized risk management tools to identify high-risk investigator sites ● Reviewed quality metric reports, audit reports, and monitoring reports to identify potential compliance risks and trends● Developed oversight plans for high-risk investigator sites in collaboration with global trial managers

● Monitored rheumatoid arthritis and oncology clinical trials● Collaborated with investigators and site staff to resolve study-related issues● Managed receipt, processing, and reconciliation of serious adverse event (SAE) reports

● Developed Protein-A HPLC method to monitor bioreactor protein concentration● Created departmental cross-training program to improve efficiency and provide career development opportunities● Initiated a laboratory data monitoring program that reduced the number of samples requiring testing● Trained and supervised new employees on all applicable assays, tests, and instrumentation● Authored SOPs, technical reports, and technical memos

Masters, Cell Biology And Biotechnology

Bs, Physiology, General