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Online Resumes with "QMS Author"
Engineering Manager - 6 years Experience, Engineering - 20 Years experience, Quality - 6 Years
SUMMARY Follows a defined process of management that consistently incorporates the voice of the customer and manufacturability within the limits of sustainable process controls. Products and processes have had higher gross margins and inherently shorter lead times than original objectives. Technically adept and intuitively leverages experience against available resources to deliver exceptional support and resolve critical i...
Tags for this Online Resume: Critical Care, Engineering, Failure Analysis, Integrate, Manufacturing, Manufacturing Engineering, Product Development, Project Management, Project Manager, Reliability, Quality, AS9100, ISO-9001, NADCAP, FDA, GMP, Aerospace, Medical, Patent, FMEA, LEAN, R&D, Operations, Budgets, Standards, Compliance, Validation, Verification, Testing, DO-160, UL, CSA, IEC, JSTD, Root Cause, Corrective Actions, Bio Pharma, Robotics, Automation, Industrial, Commercial, Manager, Sikorsky, Lockheed Martin, Boeing, 5S, MRB, SPC, IQ-OQ-PQ, Tooling, Value Added Engineering, Eraned Value Management, ROI, Profitability, DOE, Scheduling, Marketing, Trainer, SOP, QMS Author, FAIR, Life Sciences, Project Engineer, Senior Engineer, Microfluidics, HMI, PLC, Qualification, Source Inspection, Audits, Supplier Management, Obsolescence Program
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
