Director, Compliance and Validation

Description

• Develop the base plan and coordinate technical requirements with engineering disciplines
• Assist in the education and development of the team and act as resource for questions.
• Assess the requirements of a project, break a project into tasks, and work with teams to determine scope of work, budget and staffing
• Travel as required for client development and project execution
• Build and sustain long term client and internal relationships
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team
• Assign and review work of project team.
• Participate actively in relevant industry organization events and conferences
• Prepare or review budgets based on experience and scope of project.
• Innovate and improve design and service delivery method and processes
• Create integrated solutions and communicate key concepts to the client
• Research material options to deliver an optimal solution for the client when required by project scope
• Meet with clients to define the program requirements based on an understanding of the client's production process flow and space environmental needs derived from meetings with the client and the review of any documentation provided by the client
• Check progress of work and alert project leads to change of scope or additional services.
• Understand and develop design intent based on client objectives and provide excellent client service

Requirements

• Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
• Excellent time management skills and ability to multi-task on simultaneous projects
• Diverse experience in leading CQV project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable.
• Communicate and interact directly with clients in a collaborative and professional manner
• Demonstrated client development experience and excellent presentation skills
• Displayed leadership in a consulting and service environment.
• Experience with creating proposals and business development.
• Experience with financial systems, project, and client administration
• Project Management experience in managing scope, cost, schedule, quality and risk is required.
• 15+ years of Life Science operational & engineering experience in the pharmaceutical, biotech or medical device sectors - Client side & Consulting experience highly preferred
• Display enthusiasm and excitement for client projects that lifts project teams to high levels of job satisfaction
• 10+ years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects
• Experience building, managing, and leading teams
• Coordinate all aspects of project document completion within company and externally with clients and other design professionals. Proficient written and oral communications skills.
• Strong leadership, verbal communication, technical writing, project management tools and word processing skills.
• Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
• Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
• BS Degree in Engineering or related technical degree

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance