Mark McGee

I am a 5th degree black belt in Shotokan Karate, Kickboxer and Crossfitter with a passion to help people and companies achieve their inner Awesome.

What I Do:

I analyze current state workflows, consult with subject matter experts, and implement other systems and processes to support the future state workflows, employees and clients. I also develop the training, tools and resources to ensure the business results exceed expectations. My projects have consistently produced positive results with one series of projects resulting in a $7.2 million increase in revenue in less than 12 months.

Transformation Examples:

• Increased departmental revenue by $7.2MM by decreasing cycle time.
• Decreased Retesting rate from 20% to 4%
• Increased reporting effectiveness by 100% in 6 months
• Decreased the number returned products by 300%

Industries:

Quality Management and performance improvement concepts are universal, not industry-specific. I have worked or consulted in a variety of industries, including pharmaceutical, biologics, medical devices, healthcare, manufacturing, document management, and fitness.

I am familiar with all Pharmaceutical Quality Systems Regulations - 21 CFR 11 (Electronic Records/Signatures), 21 CFR 203 (Prescription Drug Marketing), 21 CFR 211 (GMP for Finished Pharmaceuticals) , 21 CFR 820/ ISO 13485 (Medical Devices), Corrective and Preventive Action Programs (CAPA), and European and Japanese Pharmacopoeia.