Project Manager – Quality & Regulatory Affairs

Marlborough, Massachusetts
February 12, 2026
$56 - $63 / hour
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Job Description

Job Summary:

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

Duties and Responsibilities:

Leads projects:

  • 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 projects:

  • Owns the timeline, budget, resource constraints, and deliverables/results.
  • Shifts between the “big picture” and the small-but-crucial details.
  • Is prepared to roll up their sleeves and work through detailed issues.

Manages projects:

  • Ensures all appropriate tools are completed and used effectively (e.g., charter, Gantt chart, status updates).

Communicates:

  • Actively communicates with project sponsors and stakeholders.
  • Establishes regular points of communication.
  • Manages sponsor and stakeholders expectations.

Delivers the expected results:

  • Performs root cause analysis on project shortfalls and takes corrective action as necessary.
  • Applies project management tools and techniques toward a variety of large, and 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 aProductst the integrated set of milestones and deliverables.
  • Documents business processes.

Education & Certifications:

  • Bachelors 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.

Experience:

  • Demonstrated experience leading large or complex projects with multiple workstreams from initiation to completion (7-10 years experience).
  • Demonstrated experience facilitating discussions or workshops.
  • Demonstrated experience leading changes.
  • Some experience with process management.

Knowledge, Skills and Abilities:

  • Demonstrated data analysis skills.
  • Demonstrated ability to influence business leaders.
  • Demonstrated ability to develop strong relationships with others.
  • Basic knowledge of VOC tools.
  • General knowledge of Hoshin and breakthrough planning.
  • 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 SmartSheet.
  • Interpersonal skills.
  • Decision making skills.
  • Planning and organization skills.
  • Negotiation skills.
  • Results-oriented.
  • Creative.
  • Persistent.
  • Composed.
  • Able to learn new concepts rapidly.
  • Able to work independently with little supervision.

Work Environment:

  • Up to 25% Travel, Domestically.

Physical and Mental Requirements:

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

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