JOB SUMMARY

The Project Manager will be responsible for planning, executing, and overseeing pharmaceutical projects in compliance with regulatory requirements, industry standards, and company objectives. This role requires strong leadership, communication, and organizational skills to ensure that projects are delivered on time, within scope, and within budget. The Project Manager will collaborate closely with cross-functional teams, including R&D, Quality, Manufacturing, Regulatory Affairs, and external vendors.

QUALIFICATIONS

• Bachelor’s degree in Engineering, Sciences, Supplier Management, or a related field.
• PMP or equivalent certification is a plus.
• Minimum of 5–8 years of project management experience in the pharmaceutical or biotech industry.
• Proven track record managing capital projects >$1M.
• Strong understanding of GMP, FDA regulations, and validation processes.
• Excellent communication, leadership, and organizational skills.
• Proficiency in project management tools (e.g., MS Project, Primavera, SAP).
• Proficiency in computer programs: Microsoft Office (Word, Excel).
• Skilled in managing and resolving complex, cross-functional challenges through technical expertise, creative problem-solving, and innovative approaches.
• Fluency in English and Spanish languages (written/spoken).
• Background in Automation and Computer Systems Validation (CSV), with a deep understanding of industry’s best practices.
• Skilled at fostering win-win solutions among diverse stakeholders, ensuring alignment and collaboration.

• Lead cross-functional teams to plan, execute, and deliver capital projects (e.g., facility expansions, equipment installations, utility upgrades).
• Develop project scopes, budgets, schedules, and resource plans.
• Manage external contractors, vendors, and engineering firms.
• Ensure compliance with regulatory requirements (FDA, EMA, GMP).
• Conduct risk assessments and implement mitigation strategies.
• Oversee procurement and contract negotiations.
• Monitor project progress and report status to stakeholders.
• Coordinate commissioning, qualification, and validation activities.
• Ensure safety and environmental standards are met throughout project execution.