Project Manager at PSC Biotech® Corporation in Raleigh/Durham, North Carolina, United States

Job description

• PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
• Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
• We are seeking an experienced Project Manager to support cross-functional operational readiness and inspection readiness initiatives within a regulated life sciences environment. This individual will be responsible for coordinating action plans, tracking milestones, managing risks and dependencies, facilitating issue resolution, and providing project governance for assigned initiatives.
• The Project Manager will serve as a key coordinator across stakeholders to drive timely execution and closure of readiness-related activities while maintaining visibility into project status, risks, and deliverables.
• Coordinate and track readiness-related actions associated with deviations, CAPAs, and operational improvement initiatives.
• Facilitate action planning meetings and ensure alignment of stakeholders on priorities, timelines, and deliverables.
• Monitor project schedules, dependencies, milestones, and due dates to support timely completion of assigned activities.
• Identify, communicate, and escalate project risks, barriers, and unresolved issues that may impact readiness objectives.
• Facilitate cross-functional triage and resolution sessions for operational flow interrupters and business-critical challenges.
• Track corrective actions, ownership, and closure status while maintaining visibility through project reporting tools and dashboards.
• Support inspection readiness activities through action tracking, gap assessment coordination, documentation management, evidence collection, and stakeholder preparation activities.
• Maintain and communicate project status updates, key performance indicators, action trackers, and leadership reports.
• Support operational readiness initiatives by managing approved work plans, milestone schedules, risk registers, and dependency tracking.
• Collaborate with Quality, Manufacturing, Engineering, Supply Chain, Validation, and other functional teams to drive alignment and execution.
• Facilitate lessons learned sessions and document recommendations for process improvements and future readiness efforts.
• Prepare final project summaries outlining completed activities, residual risks, open actions, and recommended next steps.

Responsibilities

• Coordinate and track readiness-related actions associated with deviations, CAPAs, and operational improvement initiatives
• Facilitate action planning meetings and ensure alignment of stakeholders on priorities, timelines, and deliverables
• Monitor project schedules, dependencies, milestones, and due dates to support timely completion of assigned activities
• Identify, communicate, and escalate project risks, barriers, and unresolved issues that may impact readiness objectives
• Facilitate cross-functional triage and resolution sessions for operational flow interrupters and business-critical challenges
• Track corrective actions, ownership, and closure status while maintaining visibility through project reporting tools and dashboards
• Support inspection readiness activities through action tracking, gap assessment coordination, documentation management, evidence collection, and stakeholder preparation activities
• Maintain and communicate project status updates, key performance indicators, action trackers, and leadership reports
• Support operational readiness initiatives by managing approved work plans, milestone schedules, risk registers, and dependency tracking
• Collaborate with Quality, Manufacturing, Engineering, Supply Chain, Validation, and other functional teams to drive alignment and execution
• Facilitate lessons learned sessions and document recommendations for process improvements and future readiness efforts
• Prepare final project summaries outlining completed activities, residual risks, open actions, and recommended next steps

Requirements

• Bachelor's or advanced degree in engineering or related life sciences discipline. PMP certification is a plus.
• Minimum 3-7 years of project management experience within the regulated Life Sciences industry
• Experience coordinating complex, cross-functional projects involving multiple stakeholders and competing priorities.
• Strong knowledge of project management principles, including scheduling, risk management, issue tracking, dependency management, and status reporting.
• Demonstrated ability to facilitate meetings, drive accountability, and manage action-item closure.
• Excellent verbal and written communication skills, with experience presenting project updates to leadership teams.
• Must be authorized to work in the US.
• No C2C at this time.

Skills

Required

• Project management
• Scheduling
• Risk management
• Issue tracking
• Dependency management
• Status reporting
• Meeting facilitation
• Accountability
• Action-item closure
• Verbal and written communication
• Presenting to leadership

Preferred

• PMP certification

Benefits

• Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Fitness Perks and Discounted Rates
• Financial Perks and Discounts