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

• 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

• 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