Senior Project Manager (Operational Readiness)

TL;DR

Senior Project Manager (Operational Readiness): Leading cross-functional teams to ensure the successful delivery of pharmaceutical and biologic facility projects with an accent on operational readiness, commissioning, and qualification. Focus on managing project scope, timelines, and budgets while ensuring strict adherence to GMP regulatory standards.

Location: Must be authorized to work in the US; role is based in Holly Springs, United States.

Company

hirify.global provides essential services to the life sciences industry, ensuring healthcare products are developed, manufactured, and distributed in compliance with global regulatory requirements.

What you will do

• Lead cross-functional project teams to execute facility start-up, commissioning, and qualification activities.
• Define project objectives, scope, and deliverables while tracking schedules and budgets.
• Develop and implement operational readiness plans, including SOP development and training programs.
• Identify and mitigate project risks to ensure seamless transitions from construction to operations.
• Collaborate with manufacturing, quality, and engineering teams to ensure GMP compliance.
• Coordinate communication between internal stakeholders, government agencies, and external vendors.

Requirements

• Bachelor's degree in engineering or a related life sciences discipline.
• Must be authorized to work in the US.
• 5+ years of project management experience in the life science industry.
• Proven background in drug development, product launch, and facility start-up.
• Experience leading operational readiness initiatives for GMP manufacturing facilities.
• Advanced knowledge of industry regulations and guidelines.

Nice to have

• PMP certification.
• Experience in proposal, contract, or grant writing.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance with 100% premium coverage for employees.
• 401(k) plan with company matching.
• Generous PTO, sick time, and paid holidays.
• Education assistance and professional development support.
• Additional perks including pet insurance and fitness discounts.