As an Experienced Manager of People; I Understand the Principles of Good Leadership And

As an experienced manager of people; I understand the principles of good leadership and management. Specifically; I have successfullydirectly managed as many as 40 employees at Cardinal Health and led a team of 11 in the remediation effort at Boston Scientific. I have been involved in IT governance where I have been responsible for delivery of solutions and governance metrics. For example: I am currently leading the 6 highest priority projectsout of 35 must have in the Mylan Pharmaceuticalsspanning 44 sites across the globe. This work involves communication of metrics, resolving issues and aligning with critical stake holders in the IT/QA organization

I am comfortable in roles with high visibility. My strategy is typically tailored to each specific company; taking advantage of what works,while being keenly aware of the impact of every decision I make throughout the organization. My philosophy is always to work under the company philosophy and overall strategy (acquisitions also require strategy for assimilation), I work hard to communicate well with stakeholders, identify what needs to be done and prioritize the execution. My experience in Global Project Management has a profound influence on what I do. I understand the principles of PM/PBOK though the science of it from Oklahoma State University Graduate School and hope to test my proficiency through PM Certification in future. My experience however has been my best teacher. My current project portfolio has 3 projects of over 3.5 Million. In one, I have over 29 main stakeholders separated geographically by time, language and culture. Scheduling meetings, action items, and cost estimationsis a real art.

Any solution proposed needs to fit the organization. One solution never covers all. It has to be customized to the organization and the most important priorities for the company. The system designed must be Risk Based, Flexible and Scalable. I have applied both this principles in Boston Scientific (merging several unrelated systems to one system) after the acquisition of CRM and Guidant. Smith and Nephew (a global Quality System) that included Software as a device, RJ Reynolds (emerging regulations) all from scratch where no regulations ever existed among others. I am proficient in GAMP 5 Methodologies, BS EN 62304, CAN, EUamong others. I was invited last year to join the GAMP committee for Emerging Regulations.

I have successfully validated over 400 computer systems in my career. I have played the role of a PM to these projects, Lead, Quality Assurance. In short, I really do have mad technical Skills in Validation (especially in computers/ software). In my experience I have validated Local and enterprise solutions such as SAP, MES, JD EdwardsAmong many others.

Writing technical documents has never been a challenge. I know how to develop Policies, SOP’s and WI. Championing processes developed has been the greatest challenge. There are many ways to do the same thing so the hardest work involves managing change and setting constraints to ensure the integrity of the whole.

My understanding of business processes from a QA perspective provides me an edge. I have applied six sigma methodologies, sought to optimize of existing processes though the Lean initiatives. I am a champion for lean and mean where companies must remove the fluff in processes and red tape while allowing for common sense to permeate.

I have significant International, Regulatory and Auditing experience specifically I developed an offshore delivery centers in Noida, New Delhi- India (45 Engineers), Aarau, Switzerland and Germany. I am currently scheduled to travel to Nottingham, UK and Berlin, Germany for evaluation and audit of servers. My international assignments have included GAP Analysis, System Audits, Remediation, Quality System Alignments and Training. My regulatory experience include FDA regulations, SOX, EU among others.

As a person, I believe I have qualities that will likely allow me to succeed. These include the fact that I am young (in my 40’s) and seriously seeking a long term job and can handle significant work and travel requirements. I come from a very stable home, I am naturally self-aware and simple. I have a vast educational background in Science, Engineering and Computer Science. I have excelled in athletics to All American Status in Track and Field and World intervarsity Games in Fukuoka Japan. I am highly motivated, driven by change, empathic, understanding and communicative. I have a natural yearning to continuously learn and teach. I am organized and thorough …sometimes too much. I am still learning how to strike thatwork/home balance.

Denis Machoka

Phone 515 339 6199 ǀ