Pharmaceutical Manufacturing Operations Workstream Lead

2 weeks ago


California, United States Cpl Full time

Seeking a Pharmaceutical Manufacturing Operations Workstream Lead to support the supply chain/quality team


Responsibilities 


⢠Assess and review current practices, advising on appropriate strategies to correct compliance gaps through intermediation controls and/or sustainable corrective/preventive actions. 

⢠Working with regulatory affairs to understand, interpret on agreed CMC submission strategies/commitments for approved products. 

⢠Building best practices, skills, and capability throughout the site organization, with the focus in the Operations, Engineering, and MS&T (Manufacturing, Science and Technology) functions. 

⢠Apply pharmaceutical operational and quality knowledge to highlight inter-process, systems and capability relationships and related activities that require improvement. 

⢠Working with Senior Management, conduct compliance risk assessments, trend analysis, provide and communicate recommendations for compliant business activities. 

⢠Prepare and present project update reports to senior management as required. 


Requirements


⢠+8 years of experience in the Pharmaceutical Industry

⢠Proven delivery of large to medium scale CMC and Consent Decree projects involving manufacturing, quality, supply chain and regulatory affairs in support of commercial products. 

⢠Previous experiences working with FDA and participating in regulatory agency inspections. 

⢠Extensive experience in quality, manufacturing, or MS&T departments of a commercial pharmaceutical manufacturing company.

⢠Technical Experience in Validation, GMP/GLP Compliance, Pharmaceutical Engineering, Quality Assurance & Control, Regulatory Affairs, and Manufacturing Operations. 

⢠Experience in Quality Management Systems, Quality Assurance and Compliance would be beneficial.

⢠Desired experiences in project management, change management, quality systems, quality assurance, validation, and manufacturing operations.


If you are interested, please contact madison.simon@cpl.com



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