QvalFocus Inc. · 4 hours ago
Senior Project Manager
Charlotte, NC
Contract
Onsite
Senior Level
7+ years expQvalFocus Inc. is seeking an experienced Senior Project Manager to lead and manage cross-functional projects within a regulated GMP environment. The ideal candidate will have strong experience delivering projects in pharmaceutical, biotech, or medical device settings while ensuring full compliance with FDA and quality regulations.
Staffing & Recruiting
Hiring Manager
Kasi Viswanadh Mathukumalli
Responsibilities
Lead end-to-end GMP projects including manufacturing, validation, quality, and regulatory initiatives
Develop and manage project plans, timelines, budgets, and risk mitigation strategies
Coordinate with cross-functional teams: Quality, Manufacturing, Engineering, Validation, Supply Chain, and Regulatory
Ensure all project activities comply with GMP, FDA, and internal quality standards
Track milestones, deliverables, and dependencies; proactively resolve issues
Facilitate project meetings, status reports, and stakeholder communications
Support change management, deviations, CAPAs, and audit readiness activities
Manage vendors, contractors, and external partners as required
Drive continuous improvement in project execution and documentation practices
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field
7+ years of project management experience in a GMP-regulated environment
Strong understanding of GMP, FDA regulations (21 CFR), ICH, and quality systems
Hands-on experience managing manufacturing, validation, or quality projects
Proficiency with project management tools (MS Project, Smartsheet, Jira, or similar)
Excellent communication, documentation, and stakeholder management skills
Preferred
PMP or similar Project Management certification
Experience with facility expansions, tech transfers, equipment installations, or process improvements
Background in pharmaceutical or biotech manufacturing operations
Experience supporting FDA audits and regulatory inspections
Company
QvalFocus Inc.
QvalFocus: Focused on Delivering Quality that sets us Apart.
51-200 employees
H1B Sponsorship
QvalFocus Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (18)
Funding
Current Stage
Growth StageCompany data provided by crunchbase