
MB&A
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We provide recruiting, consulting, and crisis management services to Life Sciences companies.
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Project Manager – Design Control Remediation Program
MB&AWe provide recruiting, consulting, and crisis management services to Life Sciences companies.
• Lead end-to-end program management for the Design Control Remediation initiative, including planning, scheduling, risk management, budget tracking, and reporting. • Establish and maintain the master program schedule, milestone tracking, and dependency mapping across all workstreams. • Serve as the primary point of escalation for program risks, issues, and resource conflicts. • Provide dotted-line operational oversight to 6–8 MB&A consultants assigned to the program (consultants report directly to MB&A's CEO). • Coordinate consultant assignments, deliverable cadence, and quality of work product against program milestones. • Identify performance, capacity, or scope issues that cannot be resolved at the consultant level and escalate promptly to MB&A's CEO. • Act as the single intake point for all client-side resource requests, controlling the source and flow of work into the consulting team. • Prioritize and sequence work to align with the client's tight remediation timelines and the criticality of compliance deliverables. • Maintain a transparent, auditable record of intake, prioritization decisions, and resource allocation. • Lead weekly client steering committee calls, including agenda, materials, and follow-ups. • Deliver a minimum of one monthly executive readout to MB&A's CEO and the client's executive leadership, summarizing progress, risks, decisions required, and forward outlook. • Maintain a high standard of executive-ready written and verbal communication; represent MB&A as a trusted partner at the leadership table. • Ensure program activities — including DHF assessments, design review facilitation, traceability remediation, V&V protocol development, and EU MDR technical documentation updates — are delivered to MB&A and client quality standards. • Drive disciplined documentation close-out and deployment.