Aug 2009 - Sep 2011
Masters of Business Administration
University of North Carolina at Chapel Hill, Kenan-Flagler Business School
Oct 2010 - Present
Global Program Head, QA Training
Direct corporate technical training program for over 1500 employees across three manufacturing sites, manufacturing five commercial products and supporting over ten clinical products, and building over technical 150 curricula, streamlining processes and simplifying the training program.
Directly manage a team of twelve (12) training professionals, instructional designers, and project managers to design and deliver curricula and training materials supporting the compliance, manufacturing, and release of products generating $4.7 Billion in annual revenue.
- Implemented global "Quick Wins" such as training helpdesk for customer support and e-learning offerings, allowing better use of resources, establishing tools for data trending to identify improvement opportunities.
- Created a portfolio to highlight various trainings designed using ADDIE model, highlights include: GMP Refresher blended learning, Inspection Behavior video, Documentation classroom training, and e-learnings.
- e-learning including: ISOTrain Coordinator software training, BRIDGE engineering software training, GMP Refresher, GMP Devices training, Trackwise software training
- Blended learning including: GMP Refresher, Inspection Readiness, Good Documentation Practices, Aseptic Techniques
- Workshops including: Good Documentation Practices, Writing Investigations, Core Compliance (GMP 100)
- Self-Paced Learning including: Scientific Theories, Lab Assay Background, GMP Principles
- On-The-Job Training including: Lab Principles, Lab Assays, Skills checks, Manufacturing training
- Evaluate multiple Learning Management Systems (LMS) and implement globally.
- Present and serve as Subject Matter Expert during Regulatory and Partner inspections
- Instituted flexible training processes for Clinical versus Commercial manufacturing campaigns
- Established shared curricula for all of Pharmaceutical Operations division, simplifying and streamlining training requirements for the division, resulting in a 40% reduction of overall requirements.
- Reduced non-value added training events by 90% focusing on compliant employee education.
- Set budget for department, staff development and organization-wide learning activities.
- Proactively built relationships throughout management levels and understood the voice of the customer.
- Established a qualified vendor process and list for training design and development.
2011 - Present
Product Quality Manager
Strategic member of the Chemistry, Manufacturing Controls (CMC) team for Tysabri®, which generates more than $1 Billion (US) annually, and 2 clinical programs. Direct all Quality Assurance and Quality Control related actions for the manufacture, supply chain, release, regulatory, and post-marketing activities for productsglobally. Manage multiple key relationships to assure product quality attributes are met for assigned products.
Manage teams globally directing quality activities relating to Tysabri®and assigned clinical programs. Core member of strategic CMC teams, leading teams and serving as subject matter expert on all manners of Quality as they relate to assigned clinical programs and Tysabri®. Direct multiple partnered programs as Quality lead, internal and external, globally.
- Serve on CMC teams, with key inputs to product strategy regarding marketing, regulatory filings, and process improvements.
- Author Item Specifications and supporting information for internal and external products (Drug Substance and Drug Product).
- Authored Annual Product Review (APR) for Tysabri®, achieving first on time completion of APR at Biogen Idec.
- Managed multiple product and partner relationships, building networks for efficient and effective execution of Quality activities.
- Support Process Validation for improvement initiatives globally, working extensively with the Hillerod, Denmark site.
- Support the evaluation and implementation of new Reference Standards and modifications to Stability protocols and programs.
- Author, review, edit, and approve Regulatory Submissions to global agencies (FDA, EMA, multiple ROW agencies).
- Support clinical studies and review early stage clinical plans and submissions.
- Secure support and agreement from partners for key strategic CMC goals across multiple products, author Quality Agreements.
Jan 2008 - Oct 2010
Manager, QA Training, RTP
Direct corporate technical training program for roughly 400 employees at the RTP site, manufacturing two commercial products and supporting over ten clinical products, and supporting a global training program at the RTP site.
Directly manage a team of five (5) training professionals, instructional designers, and project managers to design and deliver curricula and training materials supporting the compliance, manufacturing, and release of products at the RTP site.
- Implemented Core Skills Program improvements to improve effectivity and efficiency of on the job training program.
- Present and serve as Subject Matter Expert during site Regulatory and Partner inspections
- Designed training programs for new manufacturing campaigns.
- Established site metrics program to provide compliance metrics to area directors.
- Worked with Quality Assurance to streamline site training curricula, ensuring compliance and effectivity of training activities.
- Set budget for department, staff development and organization-wide learning activities.
- Build an effective professional networks both at the RTP site and globally in order to advance training program and initiatives.
Jun 2005 - Jan 2008
Project Manager, Global Quality Training
Led training initiatives for ten customer departments locally totaling 40% of site employees, manage projects and teams globally using Six Sigma and HPI principles to implement training solutions for organizational issues.
Directly oversaw development of technical training curricula and management of compliance training. Led global project teams in implementing Competency Based Training and training material development with the ADDIE model.
- Reduced compliance gaps from 10,000+ events to less than 1,000 in four months.
- Established training process to reduce training time from 27 months to six months, cutting labor expenses by $750,000 annually.
- Built relationships and obtained commitments from management to advance training department initiatives globally.
- Proactively established and led Lead Qualified Trainer (LQT) teams to support deviation reduction and error proofing, continuous improvement initiatives, and transitioning between clinical and commercial campaigns.
- Proficient in classroom training, small group training, web-based training, Learning Management Systems, curricula design and implementation, and cGMP regulations.
- Received "On the Spot" and Applause Awards for outstanding service.
- Regulatory and partner inspection support and presentation as needed.
Mar 2001 - Jun 2005
Quality Control Associate
Conducted Quality Control testing, lab design, and lab management. Designed, developed, and implemented QC lab training curricula and materials for new lab associate training, contributing to six (6) week time savings of downtime due to on-boarding.
Responsible for lab supplies budget, training program, scheduling, reagent and solution preparation, equipment maintenance and cleaning scheduling, as well as product testing.
- Implemented a lab training program to teach and assess lab skills, documenting knowledge and scientific principles for various assays and procedures, creating consistency in training and lab performance and evaluation.
- Reduced overhead by 10% ($10,000) by establishing a lab inventory and tracking system, consistently met monthly forecasts within 5%; Yearly Budget Award winner for budget forecast accuracy.
- Technical writing including: SOPs, technical reports, and assay transfer reports.
- Developed assays for quality control of bulk drug product and assisted in laboratory PCR suite design.
- Participated in regulatory inspections as needed.
Jan 1999 - Feb 2001
HIV Research Scientist
VIRxSYS / Henry M. Jackson Foundation
Independently executed HIV research projects for both a start-up biotech (VIRxSYS) and a military research organization (Jackson Foundation) advancing general HIV research and developing novel therapies for development into an eventual viable treatment.
Planned and executed vector design experiments according to study design. Interfaced with high level military Principal Investigators, Investors, and Board members through regular project updates and data reviews. Created laboratory systems for inventory tracking, BSL-3 scheduling and safety, and SOP and technical document authoring.
- Nominated most likely to "Get the Job Done" by peers, chosen by lab PIs to execute experiments and design.
- Uncovered errors in Solution Inventory, saving at least $100,000 in labor and experimental design time
- Implemented SOP systems s in research-oriented setting, providing consistency and cost-savings
- Most sought-after member of junior staff to execute laboratory experiments and design.
- Experienced, innovative, creative global leader and project manager with proven business results advancing corporate business initiatives.
- Set functional vision and strategy for a team of 12 learning professionals to execute a global training strategy and compliance program.
- Internal consulting and performance improvement to deliver cost savings results - $750,000 annual savings implementing Six Sigma Greenbelt Project.
- Business savvy interacting with all levels of an organization through EVP level and building effective networks to obtain commitments for departmental initiatives.
- Shine in a dynamic and fast-paced environment, maintaining a focused, calm, and problem solving approach. Interested in serving as part of the core strategic team at a global organization.
Strategy, Innovation, Six Sigma, HPI Certification, Training, Project Management, Competency Based Training
Accomplished and innovative leader with extensive experience leading global teams in executing a corporate learning strategy. Creative and results-driven director with proven successes establishing and implementing learning strategies to support and advance business goals. Savvy professional effectively managing and developing both up and down corporate structure, building effective networks to deliver business results. Shine in a dynamic and fast-paced environment, maintaining a focused, calm, and problem solving approach. Interested in making learning and training a key success driver and part of the core strategic team at global organization.
References are available upon request.