Program Manager

LOCATION: Madison, Wisconsin Area

REPORTS TO: COO

SUMMARY OF POSITION:

Program Manager will be responsible for the organization, coordination and management of projects and plan upcoming complex projects for the R&D of Beyond Air & Beyond Cancer and their product implementation efforts. This position will work closely with the Director, Program Management & Engineering Services in developing the strategic engineering activities, timelines and budgets to meet corporate objectives.

ACTIVITIES:

• Part of an interdepartmental, International team to complete assigned projects on time, to specifications, and with accuracy and efficiency.
• Outlines the tasks involved in the project and delegates accordingly.
• Conducts cost analysis, estimating expected costs for the project.
• Prepares and implements a budget based on estimates.
• Conducts risk assessments; reports identified risks to management; provides recommendations for mitigation of risk (including termination of the project if appropriate).
• Ensures products manufactured meet company established specifications by enforcing SOP’s, DMR’s, and cGMP standards as required by the Quality Systems Regulations – CFR 820 and ISO 13485 regulations.
• Addresses questions, concerns, and/or complaints throughout the project.
• Acts as a liaison between company, customers, and vendors.
• Communicates and collaborates with sales and marketing teams to provide information required to promote new projects, programs, and systems.
• Ensures compliance with federal, state, local, industry, contractual, and company regulations, standards, specifications, and best practices.
• Performs other related duties as assigned.
• Ensures DMRs and BOMs are kept up to date, including processing of change orders as needed.
• Hands-on project management of new product development projects from requirements definition through commercialization, identifying schedules, scopes, budget estimations, and project implementation plans, including risk mitigation.
• Coordinate internal and external resources, ensuring projects remain within scope, schedule, and defined budgets, in collaboration with project staff from various functional departments including marketing, quality, clinical, regulatory, design, human factors, packaging, process development, procurement, etc..
• Establish and maintain relationships with appropriate client stakeholders, effectively communicating with all levels of the organization, providing frequent contact on project status and changes.
• Analyze project progress and, when necessary, adapt scope, timelines, and costs to ensure that project team adheres to project requirements.
• Monitor and assign resources appropriately to streamline project efficiency and maximize deliverable outputs.
• Report project outcomes and/or risks to the appropriate management channels as needed—escalating issues as necessary based on project work plans.
• Manage programs and projects from conception to product launch/closeout and manage cross functional teams to ensure project deliverables are met.
• Develop, plan, and prioritize day to day activities for program or project specifics.
• Define when programs are to set up to manage multiple connected projects setting up the method/format for the program level management.
• Identifies and negotiates schedules, milestones, and resources required to meet objectives.
• Maintain multi-functional team relationships with key stakeholder participation.
• Define deliverables for assigned projects and programs.
• Facilitate team meetings, cross functional communication, and ensure all stake holders are given appropriate information to make effective decisions.
• Define and manage roles and responsibilities while managing moderately complex projects and programs.
• Communicates expectations to project team members and holds them accountable.
• Assists and contributes to creation, facilitation, and submission of the NPD reports.
• Regularly report project updates to the executive team.
• Ensure proper scope elicitation and manage change, communication, issues, and risks to meet project objectives.
• Utilize and maintain project management tools such as project plan, risk analysis, project charter, etc.
• Develop extensive project management controls for navigating complex cross organizational boundaries.
• Continuous improvement and collaboration with other project/program managers and key stakeholders being a key driver of such improvements and contribute to organizational learning while driving the group’s ability to improve.

REQUIRED EDUCATION / EXPERIENCE / SKILLS

• BA, BSc, Engineering
• 10+ years’ experience required. 5+ years directly in manufacturing environment in Pharma / Medical Device industry
• Medical Device Experience including FDA 21 CFR Part 820
• Experience with Drug/Cancer development processes
• PMP, PgMP, CAPM or comparable PM certification is highly desirable
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Strong supervisory and leadership skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Thorough understanding of or the ability to quickly learn about the project or product being developed.
• Proficient with Microsoft Office Suite or related software with fluency in MS Project program
• Background in mechanical or electrical engineering.