Project Manager

New York Technology Partners is seeking a Project Manager – Quality & Regulatory Affairs to lead complex programs within the pharmaceutical and life sciences industries. This role involves coordinating efforts across various teams to ensure compliance with regulatory requirements and quality standards.

Responsibilities:

• Lead large, complex Quality and Regulatory Affairs programs from planning through execution and completion
• Develop and maintain integrated project plans, schedules, milestones, dependencies, deliverables, and critical paths
• Establish program governance, reporting structures, decision-making processes, and escalation pathways while managing risks, issues, actions, and dependencies
• Coordinate execution across Quality, Regulatory Affairs, Regulatory Operations, Manufacturing, Pharmacovigilance, IT, Clinical, Safety, and other business functions
• Apply Agile, waterfall, or hybrid project management methodologies based on program needs
• Ensure initiatives align with applicable regulatory requirements, quality standards, and internal policies and procedures
• Support quality management activities, including audit and inspection readiness, compliance assessments, deviation management, CAPA tracking, quality risk management, and remediation planning
• Monitor quality and compliance metrics, identify gaps or emerging trends, and oversee corrective actions through completion
• Demonstrate exceptional attention to detail and ensure all quality, regulatory, and program documentation is complete, accurate, consistent, traceable, and maintained in accordance with applicable requirements
• Support regulatory strategies, submission planning, health authority commitments, approval processes, and the coordination of submission content, documentation, reviews, and timelines
• Track regulatory milestones, dependencies, risks, decisions, and commitments, communicating potential impacts to program timelines and deliverables
• Facilitate governance meetings, working sessions, status reviews, and executive decision-making forums
• Prepare program updates, executive reports, dashboards, and presentations that translate complex quality, regulatory, operational, and technical information into clear, actionable communications
• Build strong stakeholder relationships, promote accountability, and drive alignment across cross-functional teams
• Identify and implement opportunities to improve Quality and Regulatory Affairs processes, governance, delivery practices, workflows, controls, and performance measures
• Support continuous optimization and simplification by applying lessons learned, mitigating recurring risks, and establishing sustainable solutions

Requirements:

• 10 or more years of experience managing large, complex programs or projects within the pharmaceutical, biotechnology, medical device, or broader life sciences industry
• Demonstrated experience supporting Quality and Regulatory Affairs programs in a highly regulated environment
• Strong understanding of regulatory submissions, health authority interactions, approval processes, quality management, and regulatory compliance requirements
• Experience in Quality, Regulatory Affairs, Regulatory Operations, Pharmacovigilance, or a related regulated business function
• Demonstrated experience implementing Veeva platforms and other enterprise applications within regulated life sciences environments
• Knowledge of GxP requirements and applicable quality and regulatory standards
• Experience supporting audit readiness, inspection readiness, compliance remediation, CAPA, or quality improvement initiatives
• Proven ability to manage multiple workstreams, priorities, dependencies, risks, and stakeholders simultaneously
• Experience leading cross-functional and global teams across business, quality, regulatory, technical, and operational functions
• Strong program governance, risk management, issue management, problem-solving, and executive reporting capabilities
• Exceptional attention to detail, with a demonstrated ability to produce and maintain complete, accurate, and compliant documentation
• Excellent written, verbal, facilitation, interpersonal, and formal presentation skills
• Ability to translate complex quality and regulatory requirements into clear project plans and actionable deliverables
• Proven ability to influence teams, promote alignment, and drive results without direct authority
• Proficiency with standard project planning, reporting, collaboration, and tracking tools
• Bachelor's degree in life sciences, business, project management, or a related discipline
• Project Management Professional (PMP) certification is preferred but not required
• Experience working across global Quality and Regulatory Affairs organizations is preferred