Program/Project Manager

ProQuality Network; Northern (KY); Hybrid; USD 120,000 - 150,000; Full time

Job summary

ProQuality Network is seeking a senior Program/Project Manager with extensive experience in pharmaceutical or biologics manufacturing to lead complex projects supporting site operations, infrastructure, and continuous improvement initiatives.

You will be the primary accountability for project execution, including schedule, budget, risk management, stakeholder coordination, procurement support, documentation, and reporting. Excellent English and Spanish communication are required.

Qualifications

• Experience providing PM/Program PM services in pharma/biologics with cGMP.
• Hands-on parenteral manufacturing project exposure required.
• Direct experience managing complex projects in life sciences environments.
• Able to independently manage multiple workstreams.
• Strong schedule, budget, risk, and reporting skills.
• Experience coordinating contractors, vendors, and engineers.
• Regulated manufacturing environment experience essential.
• Fluent in English and Spanish; Puerto Rico residency preferred.

Responsibilities

• Provide project governance across schedule, budget, risk, and resources.
• Develop integrated project schedules and milestone plans.
• Coordinate activities across Engineering, Operations, Quality, and Finance.
• Support cost estimating, budgeting, and capital planning.
• Procure and coordinate with contractors, vendors, and engineers.
• Maintain risk registers and mitigation plans.
• Manage change control and project documentation.
• Coordinate regulatory/permitting activities as needed.
• Prepare regular status reports for leadership.
• Support GMP compliance, validation, and commissioning activities.
• Lead planning workshops with site and corporate stakeholders.
• Assess facilities, processes, and future capacity needs.
• Develop long-range capital investment roadmaps.
• Coordinate utilities planning and infrastructure activities.
• Oversee feasibility studies and business case development.
• Coordinate design, procurement, construction, and commissioning.
• Analyze costs and drive cost-saving initiatives.
• Support startup, testing, and qualification activities.

Skills

Pharmaceutical/biologics PM

cGMP experience

Parenteral manufacturing

Multidisciplinary PM

Schedule & budget mgmt

Stakeholder coordination

Vendor coordination

English & Spanish

Regulated manufacturing

Onsite availability

Education

PMP or CCM certification

Job description

Title: Program/Project Manager – Pharmaceutical/Biologics Environment

Location: North of Puerto Rico

Eligibility: Puerto Rico Residents Only

Positions: 1

Work Arrangement: Onsite

Position Summary

Our client is seeking a senior Program/Project Manager with experience in pharmaceutical or biologics manufacturing environments to lead complex, multidisciplinary projects supporting site operations, infrastructure, planning, and continuous improvement initiatives.

The selected professional will serve as the primary point of accountability for project execution, including schedule, budget, risk management, stakeholder coordination, procurement support, documentation, and project reporting.

Required Qualifications

• Proven experience providing project/program management services within pharmaceutical or biologics manufacturing environments operating under cGMP .
• Previous hands-on experience working within parenteral manufacturing environments is required.
• Direct experience managing complex, multidisciplinary projects in industrial, pharmaceutical, biotechnology, or life sciences environments.
• Demonstrated ability to independently manage multiple project workstreams.
• Experience with project schedules, budgets, risk management, stakeholder coordination, and project reporting.
• Experience coordinating contractors, vendors, engineering resources, and other external partners.
• Experience supporting capital projects, infrastructure projects, facility initiatives, or similar technical projects.
• Experience working within regulated manufacturing environments.
• PMP, CCM, or equivalent project management certification is preferred.
• Strong communication and coordination skills in English and Spanish .
• Experience working in Puerto Rico is preferred.
• Must be a Puerto Rico resident .
• Must be available for onsite work .

Key Responsibilities

• Provide overall project governance, including schedule, budget, risk, and resource management.
• Develop and maintain integrated project schedules and milestone plans.
• Coordinate activities across Engineering, Operations, Quality, EHS, Facilities, Finance, Procurement, and other relevant stakeholders.
• Support cost estimating, budget tracking, and capital project planning.
• Support contractor, vendor, and engineering firm procurement and coordination.
• Develop and maintain risk registers and mitigation plans.
• Manage project change control and documentation.
• Coordinate applicable regulatory and permitting activities.
• Prepare regular project status reports for leadership.
• Support GMP compliance, validation, and commissioning/qualification activities as required.
• Facilitate project planning workshops with relevant site and corporate stakeholders.
• Assess existing facilities, processes, infrastructure, space utilization, and future capacity requirements.
• Develop long-range project plans and capital investment roadmaps.
• Coordinate planning for site utilities and infrastructure as applicable.
• Manage feasibility assessments, technology/vendor evaluations, and business case development for infrastructure-related projects.
• Coordinate engineering design activities and project implementation.
• Oversee procurement, construction, installation, and commissioning activities as applicable.
• Coordinate financial analysis, project performance assessments, and applicable cost-saving initiatives.
• Support startup, performance testing, and qualification activities.
• Ensure project activities are planned and executed with minimal disruption to ongoing manufacturing operations.

The selected professional will be expected to independently manage multiple related workstreams while maintaining clear accountability for project execution.

Responsibilities include:

• Serve as the primary point of contact for assigned projects.
• Manage day-to-day project coordination, including planning, scheduling, documentation, vendor coordination, budget tracking, and status reporting.
• Maintain a working-level understanding of all assigned project workstreams.
• Identify and proactively address schedule conflicts, resource constraints, risks, and project dependencies.
• Coordinate effectively with technical and operational teams to support timely project execution.
• Represent project status and key issues to site and corporate leadership.
• Maintain appropriate project documentation and decision records throughout the engagement.

Additional technical specialists may support the project as needed; however, the selected Program/Project Manager will remain the primary accountable lead.

The selected professional may be responsible for:

• Project charters and execution plans.
• Integrated project schedules and milestone tracking.
• Project status and financial reports.
• Risk registers and mitigation plans.
• Planning and feasibility documents.
• Business cases and project recommendations.
• Technical and project documentation.
• Meeting minutes and decision logs.
• Commissioning, startup, and project closeout documentation.