Tactical Client Delivery (Primary Focus) Serve as a delivery leader on tactical quality and regulatory engagements, including but not limited to: Quality Management System (QMS) assessment and remediation Inspection readiness, mock inspections, inspection training Data integrity, risk management, and compliance transformation Quality governance and organizational effectiveness Investigation responses Submission support Supplier Quality Audits Investigation system back log remediation. Prioritize tactical, complex projects as the preferred engagement type; avoid routine or staff-augmentation-only assignments where possible. Ensure delivery excellence, regulatory rigor, and strong client outcomes across all engagements. Billable Utilization & Project Leadership Maintain high billable utilization consistent with senior consulting expectations. Travel as required to support client projects, executive workshops, audits, and regulatory-facing activities. Business Development & Market Support Identify opportunities to expand existing engagements into broader or deeper quality and regulatory programs. Experience Required Bachelor’s degree in scientific, regulatory, engineering, or related discipline preferred. 3-7 years of experience in life sciences quality, compliance, or regulatory roles, including consulting and/or owner-side leadership. Demonstrated success delivering intermediate Gx. P, regulatory, and quality system initiatives. Strong working knowledge of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO). Executive presence with strong written and verbal communication skills. Willingness and ability to travel regularly in support of project delivery and client needs. Other Preferred Advanced Degree preferred Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.