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BW Design Group · 3 days ago

Business Development Director-Validation

Pasadena, CA

Full-time

Onsite

Director/Executive

$160K/yr - $230K/yr

15+ years exp

BW Design Group is a rapidly growing company with over 1,500 professionals across 45 offices in the US. They are seeking a Client Development Lead, Validation and Regulatory Compliance, to expand their presence in the Life Science market sector, leading a team for pharmaceutical, biotech, and medical device manufacturing projects.

Industrial Automation

Hiring Manager

Carolyn George

Responsibilities

Lead with an uplifting entrepreneurial spirit

Inspire excellence in all aspects of performance and project execution

Display enthusiasm and excitement for client projects that lifts project teams to high levels of job satisfaction

Consistently seek new value-add opportunities for clients and Design Group

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

Assess the requirements of a project, break a project into tasks, and work with teams to determine scope of work, budget and staffing

Communicate and interact directly with clients in a collaborative and professional manner

Create integrated solutions and communicate key concepts to 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

Research material options to deliver an optimal solution for the client when required by project scope

Assign and review work of project team

Check progress of work and alert project leads to change of scope or additional services

Coordinate all aspects of project document completion within company and externally with clients and other design professionals. Proficient written and oral communications skills

Prepare or review budgets based on experience and scope of project

Assist in the education and development of the team and act as resource for questions

Innovate and improve design and service delivery method and processes

Build and sustain long term client and internal relationships

Participate actively in relevant industry organization events and conferences

Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

Qualification

Life Science experienceValidation/Quality serviceProject ManagementClient developmentTechnical writingLeadership skillsCommunication skillsTeam managementTime managementPresentation skills

Required

A passion for a career in the Life Science industry

15+ years of Life Science operational & engineering experience in the pharmaceutical, biotech or medical device sectors - Client side & Consulting experience highly preferred

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

Demonstrated client development experience and excellent presentation skills

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

Experience building, managing, and leading teams

Experience with creating proposals and business development

Experience with financial systems, project, and client administration

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

Project Management experience in managing scope, cost, schedule, quality and risk is required

Excellent time management skills and ability to multi-task on simultaneous projects

Travel as required for client development and project execution

Displayed leadership in a consulting and service environment

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