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 [email protected]