Senior Project Manager – Quality & Regulatory Affairs (Pharma / Veeva)

Location: Boston, MA (Hybrid)

Duration: 12+ Month Contract

Position Overview

We are seeking an experienced Senior Project Manager to lead complex Quality and Regulatory Affairs initiatives within a pharmaceutical or biotechnology environment.

The ideal candidate brings extensive project management experience, strong knowledge of pharmaceutical quality and regulatory processes, and hands-on experience implementing Veeva platforms in regulated environments.

This role requires excellent cross-functional leadership, attention to detail, and the ability to manage complex initiatives involving Quality, Regulatory Affairs, IT, Manufacturing, Clinical, and other business teams.

Required Qualifications

• 10+ years of project or program management experience within the pharmaceutical, biotechnology, medical device, or life sciences industry.
• Direct experience managing Quality and/or Regulatory Affairs programs, including Regulatory Operations, Quality Management, or Pharmacovigilance.
• Hands-on experience managing Veeva platform implementations or related enterprise technology projects in regulated life sciences environments.
• Strong understanding of GxP compliance, quality management, regulatory submissions, health authority interactions, and approval processes.
• Experience with audit/inspection readiness, CAPA, deviation management, compliance remediation, or quality improvement initiatives.
• Proven ability to manage complex, cross-functional projects involving multiple stakeholders, workstreams, risks, and dependencies.
• Strong experience with project governance, scheduling, RAID management, executive reporting, and stakeholder communication.
• Exceptional documentation accuracy, organization, and attention to detail.
• Experience working with Agile, Waterfall, or hybrid project management methodologies.

Key Responsibilities

• Lead end-to-end delivery of complex Quality and Regulatory Affairs projects, ensuring alignment with business objectives and regulatory requirements.
• Develop and manage integrated project plans, milestones, timelines, deliverables, budgets, dependencies, and risks.
• Coordinate cross-functional teams across Quality, Regulatory Affairs, Regulatory Operations, IT, Manufacturing, Clinical, and Pharmacovigilance.
• Support Veeva and other enterprise application implementation initiatives within regulated environments.
• Drive regulatory readiness, quality compliance, audit/inspection preparation, CAPA tracking, and remediation activities.
• Coordinate regulatory submission planning, documentation, reviews, milestones, and health authority commitments.
• Establish project governance, facilitate stakeholder meetings, and provide executive-level status reports and dashboards.
• Identify process improvement opportunities and drive successful resolution of project risks, issues, and compliance gaps.
• Ensure project documentation is accurate, complete, traceable, and compliant with organizational standards.

Preferred Qualifications

• Bachelor's degree in Life Sciences, Business, Project Management, or a related field.
• PMP certification.
• Experience supporting global Quality and Regulatory Affairs organizations.
• Experience with complex pharmaceutical enterprise technology transformation initiatives.

Ideal Candidate

We are looking for a hands-on, detail-oriented Project Manager with deep pharmaceutical Quality and Regulatory domain experience, not a general IT Project Manager.

Successful candidates should demonstrate a track record of leading regulated life sciences initiatives, managing Veeva implementations, navigating compliance requirements, and coordinating complex cross-functional teams.

This is a hybrid position based in Boston, MA. Candidates must be able to meet the required onsite schedule.

Pay: $68.00 - $73.00 per hour

Expected hours: 40.0 per week

Application Question(s):

• How many years of project or program management experience do you have in pharmaceutical, biotechnology, medical device, or life sciences organizations?
• How many years of experience do you have directly managing Quality, Regulatory Affairs, or Regulatory Operations projects?
• How many Veeva platform implementation projects have you personally managed or led?
• Briefly describe one Veeva implementation you managed, including the Veeva product, your responsibilities, and the business function supported.
• How many days per week are you available to work onsite in Boston, MA?
• Are you able to work under a C2C or 1099 contract? W2 is not offerred for this position.

Work Location: Hybrid remote in Boston, MA 02133