Management Consultant to the Pharmaceutical Industry. Specializing in R&D strategy development, organizational development and performance turnaround. Subject Matter Expert in CMC product development. • Strategic Planning• Organizational Evaluation and Development• CMC and Laboratory Due Diligence• Quality and Compliance Audits• Remediation – FDA Form 483 and Warning Letters• Laboratory Start-Up• Laboratory Efficiency• IND/NDA review and preparation… Show more Management Consultant to the Pharmaceutical Industry. Specializing in R&D strategy development, organizational development and performance turnaround. Subject Matter Expert in CMC product development. • Strategic Planning• Organizational Evaluation and Development• CMC and Laboratory Due Diligence• Quality and Compliance Audits• Remediation – FDA Form 483 and Warning Letters• Laboratory Start-Up• Laboratory Efficiency• IND/NDA review and preparation • Analytical Methods Development and Validation• Stability Program Management and Data Interpretation • Cleaning Verification Method Development and Validation• Specifications• Selection and management of contract development and testing organizations • Laboratory Investigations Show less

QUALITY EXECUTIVE PARTNERS is a boutique consulting firm specializing in providing superior quality assurance and compliance support for your team. Our differentiating factor begins with the talent of our partners. We are focused solely on providing "only the best" QA executive leadership and professional talent. Our partners have extensive QA leadership experience in challenging situations. We are able to attract such senior talent by offering growth to our partners as QxP itself grows.… Show more QUALITY EXECUTIVE PARTNERS is a boutique consulting firm specializing in providing superior quality assurance and compliance support for your team. Our differentiating factor begins with the talent of our partners. We are focused solely on providing "only the best" QA executive leadership and professional talent. Our partners have extensive QA leadership experience in challenging situations. We are able to attract such senior talent by offering growth to our partners as QxP itself grows. QxP specializes in: -Development, Deployment and Execution of broad based GxP remediation programs; -FDA negotiations interactions, inspection preparation, management -Quality Strategy Development; -Quality Planning, Resourcing and Objective Development; -Quality System (Maturity) Assessment, Improvement, and Re-engineering -Organizational Assessment, Design, and Development; -Interim Quality Leadership; -Developing of Quality Teams and Leaders. Show less

Leadership of a contract research organization providing product development, analytical testing and clinical manufacturing to the pharmaceutical industry. • Full P&L responsibility • Operational leadership over 350 employees across 5 service offerings including Pilot Plant, Product Development, Analytical Services and Biologics services• Ensure optimum staffing to deliver customer commitments and meet financial targets• Develop business metrics to drive business… Show more Leadership of a contract research organization providing product development, analytical testing and clinical manufacturing to the pharmaceutical industry. • Full P&L responsibility • Operational leadership over 350 employees across 5 service offerings including Pilot Plant, Product Development, Analytical Services and Biologics services• Ensure optimum staffing to deliver customer commitments and meet financial targets• Develop business metrics to drive business results• Develop strategy and drive performance to deliver 15-20% year-over-year growth• Integration of Operational Excellence and continuous improvement into culture• Accountable for cGMP and cGLP compliance and other local and federal regulatory bodies • Monitor industry trends and market forces to align strategy and tactics • Develop Site strategy aligned with Business Unit strategy and drive tactical execution • Develop and execute Site Capital Plan• Customer interface to ensure satisfaction Show less