Commissioning, Qualification & Validation
Develop Validation strategies and Master Plans
Apply lean qualification approach to protocol development, based on risk assessments
Prepare SOPs and guidance documents for Validation program
GMP Quality Engineering
Quality oversight of CQV activities
Develop appropriate Quality Risk Management tools
Guidance on Change control, CAPA, Discrepancy evaluations
Program and Alliance Management
Manage core and sub project teams as required
Develop program strategies backed by timelines with project team and create and/or present Board materials
Ensure alignment on program strategies and core messaging
Lead team through initial IND filing
Prepare team for subsequent clinical phases and interactions with health authorities alongside Regulatory
Partner/vendor alliance management activities
Identify vendors suitable for your organization by managing the request for proposal (RFP) process start to end
Provide input into scope of work (SOW), master service agreements (MSA) and other key agreements
Ensure thorough technical transfers
Key liaison between vendors and company ensuring SOW is executed accordingly and invoicing in aligned with deliverables
Establish performance metrics when required
