Mike Funk Email & Phone Number

Experienced in execution of computer validation, software quality assurance, CAPA, and systems implementation and decommissioning in GxP (GLP, GCP, GMP) regulated environments (including 21 CFR Part 11 requirements) to the pharmaceutical and medical device industries. I have a keen understanding of the software development life cycle (SDLC) and its application within a scalable, risk-based approach to systems validation/implementation, including project management, business analysis, requirements, testing, change management, cloud-based computing, etc. I have a strong science background, excellent business acumen and strong customer focus.Past experience includes:- Assessing compliance status of computerized systems- Validation Manager (coaching and mentoring project teams, creating and reviewing validation deliverables, etc.)- Medical science R&D, including presentation and publishing- GLP Study Director- Management- Computer system compliance / Quality Assurance / CAPA / Change control- Working on and leading global teams- Creation and execution of computer validation deliverables (plans, tests, summaries, etc.)- Project management in support of implementation of critical, complex GLP-regulated systems (e.g., Xybion Path/Tox System and other data collection systems, environmental monitoring)- Computer system change management in support of implementation as well as ongoing compliance of systems and their ability to meet changing business needs- Developing and implementing computer validation standards and practices in support of SDLC across GLP, GCP and GMP business lines- Auditing of computer validation deliverables- Working across business disciplines in support of projects; strong customer focusSpecialties: - Working within a GxP (GLP, GCP, GMP) environment- Working on global teams- Project management- Change management- Software quality assurance- Managing cost of quality- Customer focus- Dealing with uncertainty- Able to quickly analyze root causes of problems as they arise, identify options and arrive at sound and practical solutions- Able to work independently- Excellent written and verbal skills- Six Sigma Green Belt & Lean/DFSS

Listed skills include Quality Assurance, 21 Cfr Part 11, Validation, Computer System Validation, and 20 others.