Sr. Project Manager

Proclinical Group; North Carolina; On-site; USD 150,000 - 230,000; Full time

Job summary

Proclinical is seeking a Senior Project Manager to lead large-scale GMP capital projects in pharmaceutical manufacturing, including sterile facilities. Based in Durham, you will drive end-to-end delivery from business case through CQV, coordinating Engineering, Manufacturing, Quality, and EHS teams while maintaining GMP compliance.

You will manage budgets, schedules, risk, and change controls, mentoring project teams and partnering with external A-E firms, contractors, and vendors to ensure

Qualifications

• Experience leading large-scale capital projects in pharmaceutical, biotechnology, or GMP-regulated environments.
• Proven track record of managing multiple capital projects from initiation to completion, valued at approximately $400M.
• Strong knowledge of GMP, cGMP, FDA validation, and regulatory requirements.
• Expertise in facilities, utilities, process equipment, automation, and cleanroom environments.
• Demonstrated ability to manage budgets, schedules, risks, change controls, and stakeholder communications.
• Exceptional leadership, influencing, and collaboration skills within complex matrix organizations.

Responsibilities

• Lead end-to-end execution of large-scale GMP capital projects, including sterile manufacturing and facility expansion.
• Oversee projects from business case development through design, procurement, construction, CQV, turnover, and closeout.
• Act as the primary engineering and project leadership representative for major capital investment programs.
• Collaborate with cross-functional teams, including Engineering, Manufacturing, Quality, Automation, Procurement, and EHS.
• Develop and manage project scope, budget, schedule, governance, KPIs, and execution strategies. Proactively manage risks, mitigation planning, and resolution of complex project challenges. Supervise external partners, including A-E firms, construction contractors, OEMs, and vendors, to ensure project success.
• Ensure compliance with GMP requirements, site standards, quality expectations, and EHS regulations.
• Communicate project performance, financial status, risks, and milestones to senior leadership.
• Mentor project teams and promote operational excellence through standardized project delivery practices.

Skills

Leadership

Stakeholder management

Risk management

Budgeting

Cross-functional collaboration

Education

Engineering degree

Construction Management degree

Project Management degree

Tools

MS Project

Primavera P6

Excel

Job description

Sr. Project Manager - Permanent - Durham, US

Ready to lead transformative GMP capital projects that will shape the future of sterile manufacturing and pharmaceutical innovation?

Proclinical is seeking a Senior Project Manager to lead large-scale GMP capital projects within the pharmaceutical manufacturing space.

Primary Responsibilities:

The successful candidate will focus on driving complex facility expansions and strategic investments to support sterile manufacturing, packaging, and facility growth initiatives. You will collaborate across multiple departments and external partners to ensure successful project delivery while maintaining compliance with GMP standards.

Skills & Requirements:

• Degree in Engineering, Construction Management, Project Management, or a related technical field.
• Experience leading large-scale capital projects in pharmaceutical, biotechnology, or GMP-regulated environments.
• Proven track record of managing multiple capital projects from initiation to completion, valued at approximately $400M.
• Strong knowledge of GMP, cGMP, FDA validation, and regulatory requirements.
• Expertise in facilities, utilities, process equipment, automation, and cleanroom environments.
• Demonstrated ability to manage budgets, schedules, risks, change controls, and stakeholder communications.
• Exceptional leadership, influencing, and collaboration skills within complex matrix organizations.

The Sr. Project Manager's responsibilities will be:

• Lead end-to-end execution of large-scale GMP capital projects, including sterile manufacturing and facility expansion.
• Oversee projects from business case development through design, procurement, construction, CQV, turnover, and closeout.
• Act as the primary engineering and project leadership representative for major capital investment programs.
• Collaborate with cross-functional teams, including Engineering, Manufacturing, Quality, Automation, Procurement, and EHS.
• Develop and manage project scope, budget, schedule, governance, KPIs, and execution strategies. Proactively manage risks, mitigation planning, and resolution of complex project challenges. Supervise external partners, including A-E firms, construction contractors, OEMs, and vendors, to ensure project success.
• Ensure compliance with GMP requirements, site standards, quality expectations, and EHS regulations.
• Communicate project performance, financial status, risks, and milestones to senior leadership.
• Mentor project teams and promote operational excellence through standardized project delivery practices.

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