Mike Funk

Mike Funk Email and Phone Number

Project and Validation Manager @ Arbour Group LLC
Manhattan, MT, US
Mike Funk's Location
Manhattan, Montana, United States, United States
Mike Funk's Contact Details
About Mike Funk

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

Mike Funk's Current Company Details
Arbour Group LLC

Arbour Group Llc

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Project and Validation Manager
Manhattan, MT, US
Website:
arbourgroup.com
Employees:
72
Mike Funk Work Experience Details
  • Arbour Group Llc
    Project And Validation Manager
    Arbour Group Llc
    Manhattan, Mt, Us
    View
  • Arbour Group Llc
    Project / Validation Manager
    Arbour Group Llc May 2016 - Present
    Sw Michigan
    Providing excellent computer system quality and validation support for valued clients in the pharmaceutical and medical device industries
    View
  • Ge Healthcare
    Validation Manager
    Ge Healthcare Aug 2015 - May 2016
    - Validation SME for project teams within a risk-based environment- Authored/reviewed/approved validation deliverables (requirements, plans, reports, etc.)- Oversight of testing activities in ALM including defect management- Key resource for ensuring execution of validation activities on time and on/under budget
    View
  • Ge Healthcare
    It Compliance Specialist
    Ge Healthcare Nov 2010 - Aug 2015
    - Quality oversight for implementation of GxP systems in the medical device business- CAPA and Change Control ownership/support- Creation of standards and other governance that established requirements for validation of systems- Developed job aids resource providing guidance to teams for all aspects of CSV- Developed tools for applying risk-based strategy for scaling of validation (testing) activities resulting in 30% reduction in testing cycle time and cost as well as reducing number of post go-live defects
    View
  • Gmf Consulting Services, Llc
    Computer Systems Validation And Software Quality Specialist Consultant
    Gmf Consulting Services, Llc Aug 2008 - Nov 2010
    Offering consulting services in the areas of software quality assurance, computer validation and business analysis
  • Pfizer
    Manager, Sr. Analyst / R&D Site Lead – Computer Validation, Software Quality And Business Analyst
    Pfizer Jan 1995 - Jul 2008
    Managed group responsible for the implementation and ongoing support, including system administration, of computer systems in support of GxP data gathering, analysis and reporting...including managing all aspects of the computer systems life cycle/SDLC. Business analyst and liaison responsible for working with business area and the IT organizations in order to identify and implement software solutions in response to business needs. I exited this position due to site closure.
    View
  • Pfizer
    Glp Toxicology Scientist
    Pfizer 1986 - 1995
    Bench top scientist, GLP Study Director
    View

Mike Funk Skills

Quality Assurance 21 Cfr Part 11 Validation Computer System Validation Glp Pharmaceutical Industry Fda Sdlc Gmp Medical Devices R&d Project Management Software Documentation Change Control Change Management Software Quality Assurance Process Improvement Six Sigma Gcp Software Development Life Cycle U.s. Food And Drug Administration Good Laboratory Practice Research And Development Business Process Improvement

Mike Funk Education Details

Frequently Asked Questions about Mike Funk

What company does Mike Funk work for?

Mike Funk works for Arbour Group Llc

What is Mike Funk's role at the current company?

Mike Funk's current role is Project and Validation Manager.

What is Mike Funk's email address?

Mike Funk's email address is mi****@****ily.org

What is Mike Funk's direct phone number?

Mike Funk's direct phone number is +126932*****

What schools did Mike Funk attend?

Mike Funk attended The University Of Texas At Arlington, The University Of Texas At Arlington.

What are some of Mike Funk's interests?

Mike Funk has interest in Intellectual Challenges, Home Improvement, My Family And Our Two Incredible Mutts, Photography, Hiking, Model Train Repair, Nature.

What skills is Mike Funk known for?

Mike Funk has skills like Quality Assurance, 21 Cfr Part 11, Validation, Computer System Validation, Glp, Pharmaceutical Industry, Fda, Sdlc, Gmp, Medical Devices, R&d, Project Management.

Who are Mike Funk's colleagues?

Mike Funk's colleagues are Jellie Ann Aranzaso, Jane Oira - Cornell Cpa, Mba, Cisa, Nenita Gowan, Girlie Joy Mamiit, Ali Asgar Saherwala, Samuel Gilkey, Christopher Pantollano.

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