Director GxP Training

• May 2022 - Present

Quality Assurance Training

• Jul 2020 - May 2022

Associate Director, GxP Training

• May 2016 - Jun 2020

Responsible for independently managing or through direct reports all aspects of a compliant GxP Training Program. Ensures that Good Training Practices are up to date, implemented in a timely manner, enforced appropriately, and maintained compliantly while establishing strategy and providing guidance over GxP Training for Intarcia across geographically disparate sites. Responsible for the management and maintenance of the GxP employee training records, both manual and electronic (ComplianceWire Learning Management System integrated with Veeva DMS) per regulatory requirements. Works cross functionally with department management and executive leaders in order to develop and maintain compliant manufacturing, clinical development and regulatory training and activities. Drive the creation of skill-based OJT, training curriculum supporting diverse processes, develop and deliver Inspection Preparedness, Aseptic Principles and Data Integrity Training. Serve as the key point of contact (SME) for training during regulatory inspections including FDA PAI, ISO 13485:2016, internal audits, partner audits, and due diligence efforts, as necessary. Show less

Manager - Quality Assurance Training

• Apr 2013 - May 2016

Assure GxP Regulated training compliance of multiple facilities for all Pharmaceutical Development and Manufacturing employees and GxP impacting IT and Facilities personnel. Effectively manage and develop the Training Department to ensure adequate resourcing, guidance and direction to all training personnel including 1 GMP Training Manager, 1e-learning developer, 5 Quality Systems Specialists and 4 LMS coordinators. • Lead replacement of existing Pilgrim software with more robust LMS (ComplianceWire) • Direct LMS administration, Inspection support and facilitation of Periodic Review of Training • Manage systems training for Maximo, Product Quality System, Trackwise and Documentum • Ensure the design and delivery of regulatory compliance training for over 2000 employees • Establish Web Based Training capabilities and enhanced Train the Trainer Program • Organize deviation investigations and reporting training program for three Gilead sites • Collaborate with global Gilead training to standardize policies and establish best practices • Represent training quality system to regulatory authorities Show less

Manager, Training and Development

• Jan 2008 - Mar 2013

Manage all aspects of the Baxter Biosciences Hayward site Training function to achieve strategic goals and maintain regulatory compliance. Lead deployment of 21 CFR Part 11 compliant LMS (ISOtrain), comprehensive OJT Program and evaluation of effectiveness. Manage all aspects of the Baxter Biosciences Hayward site Training function to achieve strategic goals and maintain regulatory compliance. Lead deployment of 21 CFR Part 11 compliant LMS (ISOtrain), comprehensive OJT Program and evaluation of effectiveness.

Regulatory Compliance Training Manager

• 2006 - 2007

Direct GLP and GMP regulatory compliance training disciplines on the West Coast to ensure compliance with health authority requirements and inspection readiness. Provide tactical insights to regulatory compliance training strategies. Assure implementation of new LMS and core competency program in region. Support senior management in regulatory authority inspection readiness and training inquiries. Interact with various levels of management and external consultants. Lead global, multi-functional special project teams. Develop department procedures and processes. Able to act in the supervisor’s role in his/her absence. Show less

Training Manager, Standards and Compliance

• 2005 - 2006

Learning and Development Manager

• 2000 - 2005

Training Specialist

• 1995 - 2000