Executive Director, GMP Lab

Position Summary

The Executive Director leads a state-of-the-art pharmaceutical laboratory organization, providing strategic direction, leadership, and management to the global GMP business. The Executive Director will lead the Sales and Operating Plan working in a global, matrixed environment and aligned to the GMP business unit goals and objectives. Responsible for increasing revenue, managing margin, and delivering outstanding quality data that exceeds client satisfaction by on-time delivery and execution. Partners with internal teams ranging from Operations, Supply Chain, Product Management, Finance, Engineering, Information Technology, Human Resources, and Commercial to meet business objectives and metrics. As a key member of the senior leadership team, leads BU STRAP planning, space allocation, capital projects, talent development, and leverages advanced technology to address global business challenges.

Key Responsibilities

• Provides operational leadership to laboratory services.
• Integrates operational processes, business development, research & development and quality assurance functions for optimal performance within the labs.
• Drives continuous improvement through PPI business systems and partners.
• Supports Business Development in acquiring new customers and managing relationships.
• Advises the development of new programs for revenue improvement/cost expense reduction, including post-evaluation of new implementations for effectiveness.
• Performs financial reviews, establishes operating budget and develops forecasts improving operating profit.
• Provides business updates to senior leadership.
• Sets operational standards/goals and ensures the implementation of laboratory goals and policies.
• Coordinates prioritization including space, capital equipment, scientific instrumentation and staff.
• Performs administrative responsibilities including HR functions, personnel development, facilities management, writing SOPs and PDs.
• Is responsible for the quality assurance and quality control aspects of the lab to ensure compliance with regulatory standards.
• Build project and business management bench strength (locally and globally), attracting, engaging, and developing an impactful team.

Qualifications

Education: Bachelors’ Degree in Science/Technical/Business required, advanced degree preferred. Or, an equivalent and relevant combination of education, training, & experience that provides the knowledge, skills, and abilities to perform the job.

Experience: 15+ years of leading multi-departmental clinical or analytical laboratories. Proficiency in analytical, bioanalytical or clinical chemistry platforms and methodologies. Expert business knowledge with comprehensive understanding of the organization and functional area(s) working with multifaceted audiences including executive/corporate leadership and across a large number of functional areas (product management, R&D, finance, commercial, operations, HR, etc.). Advancing leadership of team members across multiple departments, regions, and countries (10+ years). Meaningful experience with Lean / Six Sigma experience in an industrial environment is helpful.

Knowledge, Skills, Abilities: Versed in operations for pharmaceutical and biotech industries. In-depth knowledge of laboratory science, GxP, FDA and European regulations concerning relevant lab processes in drug development, method development, method validation, R&D, sample testing and data processing. Excellent communication/social skills with ability to participate in business development activities, present capabilities and solutions to clients, respond to regulatory audits, prepare and present budgets/forecasts to senior management. Expertise in budgeting, forecasting and fiscal management. Proven track record in developing and implementing strategic plans. In-depth global and cultural awareness. Knowledgeable in mergers & acquisitions and integrating business units contributing to the overall portfolio. Strong organizational agility and demonstrated drive for results. Track record of building peer relationships and developing effective teams. Detailed and process oriented, logical, but creative approach to problem solving.