Director, Compliance and Validation

Description

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

Requirements

• Excellent time management skills and ability to multi-task on simultaneous projects
• Experience with financial systems, project, and client administration
• Experience with creating proposals and business development.
• 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.
• 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.
• Demonstrated client development experience and excellent presentation skills
• Display enthusiasm and excitement for client projects that lifts project teams to high levels of job satisfaction
• 15+ years of Life Science operational & engineering experience in the pharmaceutical, biotech or medical device sectors - Client side & Consulting experience highly preferred
• Displayed leadership in a consulting and service environment.
• Experience building, managing, and leading teams
• 10+ years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated 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.
• Project Management experience in managing scope, cost, schedule, quality and risk is required.
• BS Degree in Engineering or related technical degree
• Communicate and interact directly with clients in a collaborative and professional manner
• Coordinate all aspects of project document completion within company and externally with clients and other design professionals. Proficient written and oral communications skills.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance