Sr. Project Manager

Position Overview

We are seeking a Sr. Project Manager to partner directly with the Quality organization in leading site-wide inspection readiness strategy and execution. This individual will provide full-time program leadership, coordinating cross-functional inspection readiness and Pre-Approval Inspection (PAI) activities across Quality, Manufacturing, Technical Operations, Engineering, Validation, Supply Chain, Regulatory Affairs, and other key stakeholders to ensure sustained readiness for FDA and global regulatory inspections. This role requires a highly visible leader who can effectively drive alignment, accountability, and execution across multiple functional organizations. The successful candidate will be responsible for developing and maintaining inspection readiness programs, supporting mock inspections, identifying compliance risks, tracking remediation activities, and ensuring organizational preparedness for regulatory interactions. The ideal candidate is a strategic yet hands-on leader with demonstrated success guiding pharmaceutical or biotechnology organizations through Phase III clinical development, commercial launch readiness, Pre-Approval Inspections (PAIs), and global regulatory inspections. Experience supporting drug-device combination products is strongly preferred.

Work Location

This is a hybrid position requiring a significant onsite presence to effectively facilitate cross-functional planning, readiness assessments, mock inspections, and inspection support activities. Travel may be required based on business needs and regulatory inspection requirements.

Responsibilities

• Lead the development, implementation, and continuous improvement of the organization's inspection readiness strategy and program.
• Serve as the primary project manager for Pre-Approval Inspection (PAI) readiness and regulatory inspection preparation activities.
• Coordinate cross-functional inspection readiness initiatives across Quality, Manufacturing, Technical Operations, Engineering, Validation, Supply Chain, Regulatory Affairs, and other business functions.
• Develop and maintain comprehensive inspection readiness plans, timelines, deliverables, risk assessments, and tracking mechanisms.
• Facilitate inspection readiness governance meetings, steering committees, and executive updates.
• Lead and coordinate mock inspections, inspection simulations, document reviews, and readiness assessments.
• Partner with functional leaders to identify compliance gaps, assess risks, and implement effective remediation plans.
• Drive accountability across departments to ensure timely completion of readiness actions and commitments.
• Support preparation and management of inspection-related documentation, data requests, presentations, and response packages.
• Establish and maintain inspection war room processes, communication plans, and escalation pathways.
• Monitor readiness metrics and provide executive-level reporting on inspection preparedness, risks, and remediation progress.
• Partner with Quality leadership to strengthen sustainable quality systems, inspection management processes, and operational excellence initiatives.
• Support regulatory inspections by coordinating logistics, stakeholder preparation, inspection response activities, and follow-up actions.
• Ensure inspection readiness activities align with applicable global regulations, cGMP requirements, internal quality systems, and business objectives.
• Drive continuous improvement initiatives that enhance regulatory compliance, inspection effectiveness, and organizational readiness.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, Quality, Regulatory Affairs, or a related discipline required; Master's degree preferred.
• PMP certification or equivalent project management certification is strongly preferred.
• 10+ years of experience in pharmaceutical, biotechnology, medical device, or combination product environments.
• Proven experience leading enterprise-wide inspection readiness programs and regulatory inspection preparation activities.
• Demonstrated success supporting FDA Pre-Approval Inspections (PAIs), commercial launch readiness, and health authority inspections.
• Experience coordinating complex, cross-functional initiatives involving Quality, Manufacturing, Validation, Technical Operations, Regulatory Affairs, and Supply Chain functions.
• Strong understanding of cGMP regulations, quality systems, regulatory compliance, and inspection management processes.
• Experience developing and managing project plans, risk registers, action trackers, and executive reporting.
• Experience supporting organizations transitioning from late-stage clinical development through commercialization strongly preferred.
• Experience with drug-device combination products and familiarity with FDA 21 CFR Part 4 preferred.

Skills

• Strong leadership skills with the ability to influence without direct authority.
• Exceptional project management, organizational, and execution capabilities.
• Demonstrated ability to manage multiple priorities in fast-paced and highly regulated environments.
• Strong understanding of FDA inspection processes, regulatory expectations, and compliance requirements.
• Excellent communication and presentation skills, including executive-level stakeholder engagement.
• Proven ability to identify compliance risks and drive effective mitigation strategies.
• Strong analytical, problem-solving, and decision-making skills.
• Ability to build collaborative relationships across all organizational levels.
• Highly detail-oriented with a focus on quality, accountability, and results.
• Strong facilitation skills with experience leading cross-functional workshops, readiness reviews, and governance meetings.

Benefits

• Market competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Ongoing recognition and career development opportunities.
• Generous flexible paid time off program.
• Company-paid holidays.
• Flexible working hours.
• Fully remote work options for most positions and the ability to work "almost anywhere."
• Physical office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.