Director Project Management

Job Overview:

Responsible for the overall management, direction, coordination, implementation, execution, control, and completion of specific projects ensuring consistency with company strategy, commitments, and goals.

Responsibilities:

• Act as a liaison between internal'/external stakeholders.
• Track client projects.
• Identify potential project pitfalls and coordinate with operations to apply effective strategies to overcome.
• Maintain and update project timeline to ensure client objectives are met.
• Chair project team meetings.
• Oversee and partner with the Project Managers to prepare meeting minutes.
• Manage billing milestones, capture subsequent additions to original work scope and relay information to the Business Manager/ Account Manager. 
• Ensure on-time delivery of project milestones.
• Attend external meetings as required.
• Manage client expectations and develop working relationships with client that foster business.
• Provide weekly updates to clients on project progress unless otherwise captured in meeting minutes from teleconference. 
• Cost/Budget Analysis
• Generate KPI/ reports.
• Optimize continuous improvement. 
• Negotiate with vendors/external service provider.
• Manage ANDA/NDA drug development life cycle including R&D, deficiency, optimizing processes.
• Perform other duties and assist in special projects as assigned/required.

Qualifications: 

• BS in chemistry, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Four (4) or more years of related experience, including some in the health/pharma industry.
• Project Management Professional certification (PMP) is desired.
• Demonstrate the ability to read and interpret documents such as safety rules, FDA guidelines and analytical procedures.
• Demonstrate the ability to write routine reports and correspondence. Ability to speak effectively before groups.
• Demonstrate conflict management ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exist. 
• Demonstrated experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff. 
• Demonstrate strong experience with project and people management.
• Demonstrate the ability to administer personnel performance evaluations.
• Demonstrate the ability to write and understand technical information and produce detailed reports.
• Demonstrates good leadership skills and the ability to establish and maintain good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate solid understanding/use of Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands: 

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).