• Leads quality management in the development of a robust quality system, fostering bestpractices, and mentoring and consulting on Quality/Compliance issues across the organization. • Reporting to the VP of Global Quality, this role will continually improve the QMS with the goal to maximize compliance, efficiency and effectiveness across all GxP regulations through proactive planning, training and system health metric reporting• Lead the compliance function with focus towards internal and external compliance through strong vendor management, audits as well as ensuring successful global health authority inspections.• Contributes towards the trending and reporting of quality related data to relevant staff members and senior management. Identify and address compliance gaps and opportunities to inform the Company quality policy and inspection readiness state. • Oversight of investigation/CAPA system, Complaints management, Training program and Document Management. Direct the QMR to inform senior management on key metrics for the Quality system

• Develops and implements the Quality strategy for all R&D programs including nonclinical and clinical programs. • Leads the clinical quality inspection readiness program including preparation for potential inspections at Zogenix, investigative sites, and vendors.• Ensures involvement of Quality from early phases of development through collaboration with Clinical Science, Clinical Operations, Regulatory Affairs, Pharmacovigilance, etc to influence effective processes and program oversight.• Serve as QA representative on clinical study development teams; participate in the review and approval of clinical trial “essential documents” (e.g. protocols, ICF, )• Lead and participate in cross functional working groups to identify and mitigate GCP quality and compliance issues. • Create, monitor and improve the QMS procedures with focus on development phases.

-Develops the strategy and leads the team that provides expert GxP advice (GCP, GLP, GMP) to Project Teams to mitigate regulatory agency compliance concerns-Oversees the QMS platform including process development and Quality Issues (QI)-Provides strategic evaluation of significant GxP matters, including potential Serious Breach reporting, and provide visibility to internal Business Partners-Leads the team that supports Business Partners in the creation, revision, and retirement of processes and supporting materials-Defines risk based approaches to support Business Partners with GxP trend analysis-Defines strategic and functional direction, as well as team goals and expectations that align with corporate and department objectives

-Integrated the 20+ global early phase QA audit team into the global quality and compliance organization-Implemented risk based GLP and GCP audit programs in compliance with regulations and to provide strategic leaders information on the compliance within their business units-Developed the QA training organization to provide training programs for QA team members and develop GxP training deployed company wide

-Manages resources responsible for assessing processes to ensure that systems, policies and standard operating procedures comply with national and international quality requirements for Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) for conducting scientific research. - Aligns the quality assurance processes with current industry guidelines and practices. - Provides expert quality assurance advice to Project Teams - Oversees the development of the QA Auditor training program and develops course ware regarding GxPs for the organization- Serves as a resource in responding to compliance questions and resolves compliance related issues. - Ensures QA staff effectively executes the QA Operating Plan, including the annual audit plan, approved by senior management - Effectively plans, implements, and monitors auditing functions; and ensures optimal utilization of billable auditing staff - Defines future work methodologies to better meet customer needs - Interprets regulations and guidance documents governing GxP and serves as expert and consultant to PRA staff and client representatives - Ensures all new and updated PRA SOPs are reviewed by QA for clarity, internal consistency and consistency with other related SOPs - Actively hires new QA staff and ensures new QA employees are trained and qualified to perform their tasks and contributes to training for selected PRA functional groups related to Good Clinical Practice, clinical trials regulations, and the role of QA and PRA staff

-Manages resources responsible for assessing processes to ensure that systems, policies and standard operating procedures comply with national and international quality requirements for Good Clinical Practices (GCP) for conducting scientific research. - Aligns the quality assurance processes with current industry guidelines and practices. - Provides expert quality assurance advice to Project Teams - Oversees the development of the QA Auditor training program and develops course ware regarding GxPs for the organization- Serves as a resource in responding to compliance questions and resolves compliance related issues. - Effectively plans, implements, and monitors auditing functions; and ensures optimal utilization of billable auditing staff - Defines future work methodologies to better meet customer needs - Interprets regulations and guidance documents governing GxP and serves as expert and consultant to PRA staff and client representatives - Ensures all new and updated PRA SOPs are reviewed by QA for clarity, internal consistency and consistency with other related SOPs - Actively hires new QA staff and ensures new QA employees are trained and qualified to perform their tasks and contributes to training for selected PRA functional groups related to Good Clinical Practice, clinical trials regulations, and the role of QA and PRA staff

-Leads QA auditor team by providing clear team and individual goals and expectations -Ensures team objectives achieved -Performs personally and/or ensures contracted and/or internal systems audits are completed according to client expectations and/or internal SOPs-Interprets regulations and guidance documents and serves as expert and consultant to internal staff and client representatives -Performs personally and/or ensures client and regulatory audits are hosted to facilitate the audits and minimize disruptions to ongoing operations

Planned, conducted, reported and tracked contracted operational audits according to clientexpectations and PRA SOP, including the following audit types: investigative site, database,clinical study report, vendor, and computer system validationPlanned, conducted, reported and tracked internal systems audits according to schedule andPRA SOPAssumed project management responsibility for QA-only contracted workTrained and mentored new employees on auditing techniques and PRA SOP

- Performed investigator evaluation and recruitment- Performed essential document collection, review, and maintenance- Supported project team with management of investigator sites, budget negotiation, and studysupplies- Performed routine monitoring at investigator sites

Coordinate the laboratory portion of study protocols for Phase I drug trials; Visit CROs to aid in study initiation; Review CRFs and reports for quality assurance of lab data; Design CRFs in accordance with regulatory guidelines; Develop and perform internal GLP audits for 3 laboratories; Develop and maintain the laboratory training program including new employee orientation; Write SOPs and guidelines for laboratory procedures; Submit budgets for laboratory analysis required by protocols to Clinical Scientists; Tabulate monthly metrics of laboratory workload; Present graphical representation of yearly cost savings of each section of the laboratory; Coordinate shipment of samples and study documentation from external sites.

- Head of Clinical Chemistry department in the Phase I clinical unit- Maintained QC and GLP records in accordance with FDA regulations and guidelines- Participated in validation of Laboratory Information System for use in the clinical laboratory- Notified investigators and research nurses of laboratory values of potential clinical concernwhich may indicate an adverse event- Monitored pharmacodynamic data for trending and statistical significance- Validated assays in compliance with FDA GLP regulation and guidelines