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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

Clinical Quality Assurance - 13 Years of Experience - Near 53144

SUMMARY of QUALIFICATIONS Results driven Regulatory and Quality Assurance Management Professional with 12 years Medical Device and Pharmaceutical industry experience. Proven expertise in Quality Systems, Regulatory Compliance, Supplier Quality, Product Manufacturing, Design Control, and Data Systems. Natural leader that enjoys Continuous Improvement and fostering a culture of teamwork by empowering staff to achieve collecti...

Ideal Companies: FK

Tags for this Online Resume: Compliance, Product Development, Quality Assurance, Manufacturing, Audit, Instrumentation, ISO, Management, Medical, Pharmaceutical, device, fda, Regulatory

Senior Leader in Supply Chain Leadership

I am a procurement, manufacturing, fulfillment, distribution professional with over 15 years directing large high volume, automated distribution in multiple facilities focused on quality and compliance with FDA, SEC, and governing authorities demanding excellence. ISO certification experience with in-depth knowledge of operational technologies such as MIS, WMS, TMS, CRM integration to eCommerce solutions. Extensive interna...

Tags for this Online Resume: Distribution, Fulfillment, Operations, eCommerce, Retail Distribution, Warehouse, P&L, Account Management, Compliance, Integrate

Honest, hardworking, clever, innovative. A humble visionary and leader of our time...

- Expert cross-functional team leader, problem-solver and communicator: Achieve maximum collaboration with strategic partners and build common purpose across organizational levels. - Keenly focused on driving innovative technical processes and business solutions to streamline functions and maximize revenue generation. - Talent for Business Development, leading programs, auditing, RFP proposal development, contract managem...

Ideal Companies: aerospace, aviation, airlines

Tags for this Online Resume: Reliability, System design, Control Systems, Environmental Control Systems, Hydraulics, Project Management, Project Manager, Quality, Quality Assurance, Quality Management, Program & Project leadership, Director, Business Development, Engineering Manager, Engineering Director, Regulatory Manager, Aviation / Aerospace, Manufacturing & QMS / ISO, Airlines, Safety Management Systems (SMS), MRO (Part 145)

Manager - 30 Years of Experience

I want to be able to use my existing expireence an knowledge to integrate into my new company to support the mission and goals and to support the continual improvement and customer satisfaction while focusing on the bottom line and still keeping the workplace and upbeat and positive environment for the team and staff. I want to be an integral and valued part of the management team and grow along with the company.

Ideal Companies: upper senior level management positions headhunter ats

Tags for this Online Resume: Maritime Operations, ISO/ QMS, Project Management, Port Captain, Client Manager, Microsoft Office, Continual Improvement