Project Manager – Quality & Regulatory Affairs

Job Title:
Project Manager – Quality & Regulatory Affairs

Duration: 11 months

Location: Marlborough, MA

This position will lead or support a variety of large to medium size projects within Quality and Regulatory Affairs function.

• Leads projects and working teams to effectively initiate, plan, execute, monitor, and close projects.
• Leads projects through issues, roadblocks, and problems.
• Acts as a change agent to drive teams toward success.
• Guides team members to perform through issues and constraints.
• Owns the timeline, budget, resource constraints, and deliverables/results.
• Shifts between the "big picture" and small-but-crucial details.
• Is prepared to roll up their sleeves and work through detailed issues.
• Ensures all appropriate tools are completed and used effectively (e.g., charter, Gantt chart, status updates).
• Actively communicates with project sponsors and stakeholders.
• Establishes regular points of communication.
• Manages sponsor and stakeholder expectations.
• Performs root cause analysis on project shortfalls and takes corrective action as necessary.
• Applies project management tools and techniques toward a variety of large, likely inter-related projects.
• Establishes and leads programs comprised of multiple projects, including designing how information is rolled up and cascaded down, operating rhythms and mechanisms, and tracking against the integrated set of milestones and deliverables.
• Documents business processes.

• The normal performance of duties may require lifting and carrying objects.
• Walking and/or standing.

• Demonstrated experience leading large or complex projects with multiple work streams from initiation to completion (7-10 years experience).
• Demonstrated experience facilitating discussions or workshops.
• Demonstrated ability to develop strong relationships with others.
• Demonstrated experience leading changes.
• Demonstrated ability to influence business leaders.
• Some experience with process management.
• Basic knowledge of VOC tools.
• General knowledge of Hoshin and breakthrough planning.

• Demonstrated data analysis skills.
• Problem solving skills.
• Effective written and verbal communication skills across multiple formats: formal presentations, meetings, conference calls, e‑mails, and memos.
• Skilled in Microsoft Word, Excel, PowerPoint, and Project.
• Skilled in Smart Sheet.
• Interpersonal skills.
• Planning and organization skills.
• Able to learn new concepts rapidly.
• Able to work independently with little supervision.

Up to 25% travel, domestically.

• Bachelor’s Degree – REQUIRED.
• Formal training in project management or continuous improvement methodologies (e.g., Six Sigma, Total Quality Management, Lean, Theory of Constraints) – Preferred.
• PMI Project Management Professional (PMP) – REQUIRED.