POSITION TITLE: Associate Director of Project Services (Consulting) Pharmaceutical and Biotechnology

OPEN: 6/30/2022 - 7/31/2022

POSITION DUTIES:
This role may require up to 75% of domestic travel. Responsible for managing and driving the Project Management Program and team members for PTI. Work directly with the Exec. Vice President and Director of Operations for PTI in assisting with the development and growth of clients, projects, and project team members. Develop and maintain a training program for Project Management, to be used to identify, train and help certify future PM’s for PTI. Liaise with project stakeholders (Building Owners, Contractors, Architects, Engineers, Vendors, and Management) on an ongoing basis for client projects. Develop, support and apply company process guides as well as industry regulatory standards to ensure project quality delivery. Lead, develop, and execute strategies and governance focused on Project Management and process improvements for the Project Services department. Assist in developing and driving portfolio management and cross functional standardization strategies. Mentor junior Project Managers and work with their managers to develop goals and objectives in support of advancing their career opportunities Drive continuous improvement and project management training. Prepare and deliver various project reports and documentation such as progress reports, functional test procedures, meeting minutes, checklists, issues logs, and specifications. Review and guide project teams in projects requiring development of SDLC documentation. Utilize understanding of Validation using risk-based approach. Lead, develop, and execute strategies focused on Project Management and process improvements. Provide oversite of projects following GAMP, 21 CFR Part 11, ISO and other industry specific regulatory guidance. Author and review various documentation and drawings to ensure any and all document changes meet quality and validation requirements and are in full compliance with regulations and standards. Perform system deficiency identification and resolution analysis. Identify potential risks to project during commissioning and develop potential solutions. Plan, schedule, and track project timelines and milestones using appropriate tools and other duties as assigned. Manage project financials including estimates, budgeting, and forecasting. Work both independently and within a team or collaborative environment. Effectively manage global teams virtually. Adapt to shifting priorities, demand, and timelines through analytical and problem-solving capabilities. Maintain strong working partnerships with Project Management peers and industry subject matter experts in various global regions for development, and marketing strategy. Communicate with global client executives for project planning and updates. Ability to read communication styles of team members and contractors who come from a broad spectrum of disciplines and cultures. Clear demonstration of strong negotiation and influencing skills that lead to drive change. Elicit cooperation from a wide variety of sources, including upper management, clients, and other departments. Utilize in-depth knowledge of global drug development and product lifecycle management processes. Strong written, interpersonal, and oral communication skills. Proactively identify and manage project-related risks and issues. Proven decision-making skills leading to successful solutions. Ability to effectively prioritize and execute tasks in a high-pressure environment. Position supervises 3 peers and 5-6 subordinates depending on project size.

REQUIREMENTS:

• Bachelor's Degree in Management Information Systems, Science, Engineering or the equivalent.
• Master’s of Business (MBA) or the equivalent.
• Current Certification as a Project Management Professional (PMP).
• Documented 5 years of pharma, biotech, and medical device industry experience.
• Minimum of 5 years of documented experience in Project and Program Management for medium to large scale global project management experience including aspects of process development, personnel management and execution.
• Minimum 5 years demonstrated experience in personnel management and leadership.
• Experience managing IT SDLC based projects.
• Post-secondary education in pharmaceutical or biotech processes or equivalent training is a plus.

LOCATION OF EMPLOYMENT: Cary, NC / Denver, CO / Other Location
Applicants may apply directly for the role by sending their resume to careers.us@pharmeng.com for consideration.