ABOUT CRITICAL PATH INSTITUTE (C-PATH)

Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, cost, and risk in developing and approving new therapies. For over ten years, we have partnered with industry and academic experts to advance technologies across the spectrum of medical product development from research to regulatory approval. As a leading nonprofit organization dedicated to fostering collaboration and promoting data sharing in the precompetitive space, C-Path has been at the forefront of numerous advances designed to get new treatments to patients quicker. Our continuing success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world.

POSITION OVERVIEW

C-Path's Operations team consists of Human Resources, Finance, Legal, IT, Portfolio Management, and administrative functions. We are looking for a purpose driven, self-motivated, process-oriented Compliance Project Manager with experience managing quality assurance or compliance activities. Under the supervision of the Portfolio Management Director, the Compliance Project Manager will work directly with internal and external stakeholders to ensure C-Path remains compliant with governing and certifying body requirements. He or she will coordinate with other departments to ensure all compliance-related processes are managed efficiently and documented effectively. If you enjoy collaborating with other professionals who are committed to delivering innovative solutions that make a difference, we encourage you to apply.

SUPERVISORY RESPONSIBILITIES

None

CORE DUTIES/RESPONSIBILITIES

• Establish measurement and monitoring framework for C-Path's compliance-related activities.
• Actively monitor C-Path's documentation to ensure that we remain compliant with applicable requirements.
• Apply risk-focused planning for team initiatives, investigations, and continuous improvement plans.
• Partner and collaborate across the business to establish and follow up on mitigation plans and outline business cases for projects resulting from the risk assessments.
• Identify opportunities for process improvement and work with internal stakeholders to map out and implement efficient and effective changes.
• Participate in compliance improvement projects to ensure the consistent development and implementation of interdepartmental and cross-functional team projects.
• Develop strong and influential relationships across senior levels of an organization and manage/lead project teams and multiple work streams to develop and maintain change control processes.
• Manage the Information Security management System (ISMS) and comply with all relevant auditing metrics.
• Lead Internal and External ISO 27001 Audits.
• Develop and track project plans, timelines, budget, and milestones, and take corrective action when needed and applies project and change management principles to projects.
• Prepare, facilitate, and provide status updates to internal and external stakeholders.
• Proactively solicit feedback from supervisor/manager prior to finalizing project related deliverables.
• Write concise and accurate reports, proposals, and other supporting materials.
• Drive consensus among stakeholders on key decisions.
• Ensure project documents are complete, current, and stored appropriately.
• Travel on occasion for out-of-town meetings (max 5-10%)

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Professional conduct with the ability to adapt to shifting priorities, demands, and timelines.
• Experience working in a quality management system or ISO certified organization is preferred.
• Working knowledge of budgeting concepts, terminology, and forecasting.
• Outstanding oral, written, and virtual communication skills
• Proactive time management and problem-solving skills.
• Ability to Work independently and in a team-oriented, collaborative environment.
• Demonstrated ability to consistently meet challenging deadlines.
• Sound business judgment.
• Demonstrated ability to develop relationships across multiple teams, and at all levels of an organization and work on project teams and multiple work streams in a changing environment.
• Knowledge and experience with compliance as it relates to Federally funded projects and programs.
• Ability to articulate complex issues concisely and communicate effectively and comfortably with senior level colleagues.
• Expert use of Microsoft Office Suite: Word, Excel, PowerPoint, and Outlook. Proficiency with MS Project and SharePoint.
• Proficient use of standard office meeting/communication software including Teams or Zoom

REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's degree in business, Management Information Systems, engineering, computer science or scientific fields.
• 3 years' experience managing quality assurance and/or compliance related activities is required.
• PMI certification preferred or 4-7 years of formal project management experience.
• Other certifications preferred: PMP, or ISO 19011 - Internal Auditor Certification preferred.

Critical Path Institute is an equal opportunity employer. Visit our website at www.c-path.org

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

Covid-19

All employees must vaccinate to safeguard the health and safety of our employees and their families and the community at large from COVID-19.

Reasonable Accommodation:

Newly hired employees in need of an exemption from this policy due to a medical reason or because of a sincerely held religious belief must submit a completed request for accommodation form to the human resources department to begin the interactive accommodation process as soon as possible. Accommodations will be granted where they do not cause C-Path undue hardship or pose a direct threat to the health and safety of others. Please direct any questions regarding this policy to the human resources department.