Frankfurt, Hesse, Germany
A seasoned executive with extensive experience in quality management and compliance within the pharmaceutical industry. Currently serving as Vice President and Head of Global Quality Medicine at Boehringer Ingelheim, I am responsible for maintaining a robust quality strategy and ensuring the effectiveness of the Quality Management System (QMS) across the organization. My role involves leading the Quality Medicine team, driving quality-driven strategies, and managing quality business partnerships. I'm a key member of both the Global Medicine Leadership Team and the Global Quality Executive Leadership Team, reporting directly to the Chief Medical Officer and indirectly to the Chief Quality Officer. Prior to my current role, I held several leadership positions at Boehringer Ingelheim, including Executive Director of Global Quality Excellence and Compliance, and Executive Director of Medical Compliance, Quality, and Training. My career also include significant roles at Biogen, Novartis Vaccines and Diagnostics, and Eisai Inc., where I developed and implemented quality management strategies, led audit processes, and ensured compliance with regulatory standards. I holds a B.S. in Chemical Engineering from the University of Puerto Rico and is a Clinical Compliance Certified Professional (CCCP).
Accountable for maintaining and driving a fit-for-purpose quality strategy for the Global Medicine organization, ensuring an adequate Quality Management System (QMS) for the evidence generation lifecycle within Boehringer, and managing quality business partnerships in/outside of Medicine. Furthermore, leading the entire Quality Medicine organization in leading and driving quality driven strategies and practices that enable excellence in the execution of evidence generation activities. In this role I am a Member of the Global Medicine Leadership Team and the Global Quality Executive Leadership Team and report directly to the Chief Medical Officer and indirectly to the Chief Quality Officer.
Accountable for defining, developing and implementing a risked based Quality Management strategy and to continuously improve the BI Medicine Quality Management System (QMS) as a member of the Quality Medicine Global Leadership Team and in close collaboration with Medicine Leadership. To ensure compliance within BI Medicine globally with BI, regulatory, and legal standards by: 1. Defining appropriate globally applicable quality standards and quality oversight for BI relating to integrated evidence generation activities (GCP, Medical Affairs, Pharmacovigilance, Epidemiology and Regulatory Affairs). 2. Leading the global Quality Medicine QMS and Compliance organization in order to ensure the implementation of one QMS within Medicine and in support of successful Health Authority Inspections and approvals, and acceleration of clinical adoption. Proactively working with other BI Quality and Compliance organizations to find synergies and address issues appropriately; as well use strong industry network connections to implement best practices. 3. Act as global process owner of the Medicine QMS, including identification and development of continuous improvement initiatives, quality governance, and leading the Medicine Quality Forum and Quality Management Review Meetings.
Lead the US Quality Medicine organization by driving and continuously improving the vision and concept of the US Medicine Quality Management System and its components. Provide strategic direction for the Medicine organization in the US through standards for processes and training, issue management through CAPAs, knowledge management, auditing and vendor management oversight, in line with the global vision for Quality Medicine. Member of the Global QM Leadership Team and in that role, provides local US insights, contributes to the global strategy and oversees global QM resources located in the US. Also, member of the US Medical Leadership Team. Direct the implementation, documentation and maintenance of a coordinated regulatory and legislative compliance program that meets the expectations of Federal, and State laws and regulations and company policy, including Corporate Division Medical Policies and procedures. Lead the implementation of risk based strategies and measures to minimize risks for patients, physicians and the BI organization in the US and lead inspection preparedness of relevant functions and to guide individual inspections by Regulatory Authorities for the US.
Responsible for independently leading the execution and improvements of audit processes and audit management systems activities, and acting as the primary contact for audit an outsourcing partner to assure adherence to corporate and R&D policies, Biogen Idec internal standards, and compliance with regulatory requirements and guidelines. Additionally, responsible for managing Audit Manager(s) and or contracted staff, when required, to enable timely execution of audits, review and approval of audit reports and responses, and being point of escalation for critical audit findings. Accountable for periodically reporting audit metrics to the Global R&D Audit Director, and supplying the Director with appropriate rationale / context for associated reports. Focused on working with an outsource partner to staff contractors to conduct GCP audits , GLP Bioanalytical laboratory QAU audits, GVP, Internal, Vendor, and Document audits,. Accountable for oversight of the audit management system activities and associated processes and systems improvements. Also, ensuring oversight and verify adequacy of auditing to required standards and working closely with Global R&D Audit Director to inform the annual Audit Plan. Per the Director of Audit, implementing changes to relevant auditing processes based on industry trends, gaps identified through BIIB prior audits and inspections, and insights identified through the R&D QMS.
Accountable for proper execution and completion of audits based on the CQA audit program and CQA Standard Operating Procedures. Take a lead role in tracking progress of projects/studies to be audited for planning and scheduling purposes as assigned according to the global audit program (Primarily for the North America and LatAm Regions). Independently lead study audits at investigator sites globally. Execute document audits such as, Clinical Study Reports and Safety Reports and other audits and assessments, as required. Take a lead in proper assessment and conduct of internal system audits and vendor and CRO audits as specified in the audit program. Prepare written audit reports using the audit report database and report templates. Accountable for proper evaluation; adequacy and completeness of corrective and preventive action plans (CAPA). Participate and/or lead process improvement initiatives as it relates to CQA auditing and related processes and ensures measuring the effectiveness of such initiatives. Maintain required knowledge of applicable regulations, industry and company GCP standards and procedures. Serve as an advisor on GCP related topics, in collaboration with Clinical Quality Operations group; contribute to CQA GCP forum presentations, development, and execution of other trainings as required. Support and lead site preparation for regulatory inspections globally (Asia, US and LatAm) and submission supporting activities. Trained junior staff Clinical QA on auditing practices and techniques. Manage 4 contract auditors to support the execution of the audit program. Act as the company’s Clinical Service Provider Qualification Manager and CQA Strategic Point of Contact in preferred vendor partnerships.
Responsible for planning and conducting all types of clinical service provider (CROs, specialty vendors and Phase I clinics) audits (for example, Routine, Biennial, Follow Ups) in order to assess GCP compliance with regulatory authorities, Eisai SOPs, Study Specific Requirements and vendor SOPs. Since joining Eisai have participated in approximately 80 clinical vendor audits and have been involved in four (4) international investigator site audits (Phase 2). Additionally, I was accountable for timely generation of Audit Reports (initial and final) and follow up on audit findings with the corresponding vendor according to Eisai’s Clinical Quality Assurance procedures. In charge of interaction with vendor and Eisai personnel to address and discuss observations and agree on Corrective Action Plans. I frequently supported communication with other departments regarding vendor audit results questions. Assist CQA team in the maintenance of procedures (procedures, audit guides and strategies) to maintain consistency and accuracy. In addition, I contributed to the development of ancillary documents in order to harmonize processes amongst team members. As Global Business Administrator Lead for the quality assurance audit database (QAAD) system, lead CQA team as business project manager in special CSV projects (QAAD Upgrades). Supported the ITQM department as the CQA representative for validation projects and change control management. SOCS (Scientific and Operational Clinical Support) Talent & Achievement Recognition (STAR) Award – January 2011 Eisai representative for FDA Site Inspection in Chile - August 2012.
Client: Allergan – Waco, Texas Project: Validation of Vial Labeling Machine Unit Dose Lines7, 8 and 9 Responsible for the development and execution and deviation handling of SDLC (URS, FRS/HDS, IQ/OQ, PQ, Reports and TM) documents for high Speed Vial Labeler Machine and its Control System. Develop, plan and execute deliverables in a timely manner and according to Validation Master Plan, Manufacturing and Engineering expectations. Client: Tyco Healthcare – Mansfield, MA Project: Qualification of Corporate SPC Solution Acting Project Manager for the development and execution of SDLC (Validation Master Plan, URS, FRS/HDS, IQ/OQ, PQ, Reports and TM) documents for the customized web-based Statistical Process Control solution. Client: Johnson and Johnson (Health Care Systems) - Memphis, Tennessee Project: Facilities Qualification Acting project manager ensuring project continuity through management of qualification team and deliverables. Client: Cordis (Johnson and Johnson) - Medical Device Co. - Miami Lakes, FL Project: Manufacturing Engineering Services Lead phase A of CAPA Project working closely worked with QA, Engineering, Production and NPD Departments in order to achieve milestones. Client: Vital Signs, Inc - Totowa, New Jersey Project: Extrusion Blowmolding and Regrind System Qualification Lead the validation team through the entire validation process to comply with expectations for the new product launch. Client: Alpharma – Baltimore, Maryland Project: Re-qualification services Lead the validation team through the entire validation process to comply with consent decree commitments. Ensure development and execution of IQ and OQ Protocols, Summary Reports for Packaging and Manufacturing Equipment. Maintained compliance with Regulations, Standard Operating Procedures, and Policies.