Project Manager

The Project Manager will oversee, manage, and coordinate cross-functional projects within a GMP-regulated environment, with a strong emphasis on product lifecycle management, change control, and supply chain support. This individual will serve as a key liaison between project teams and multiple departments, ensuring successful planning, implementation, monitoring, and completion of projects impacting commercial product operations.

Responsibilities:

• Lead all aspects of project execution including planning, coordination, budgeting, timeline tracking, and reporting.
• Serve as subject matter expert in the implementation of Change Control records (CFSCRs) and lifecycle product variations.
• Coordinate changes to product structures, SKUs, and labeling through regulatory and quality systems.
• Navigate regulatory systems, artwork processes, and technical documentation for compliant product changes.
• Interface with cross-functional teams, including Quality, Supply Chain, Regulatory, and Manufacturing.
• Anticipate and mitigate schedule delays, resource bottlenecks, and cost overruns.
• Track project metrics, supply readiness, and launch milestones; communicate progress in formal reports and business forums.
• Support supply chain readiness initiatives and participate in business case development.
• Recommend and implement process improvements to enhance efficiency and compliance.
• Ensure compliance with domestic and international GMP and regulatory standards.
• May lead or mentor junior project staff and contribute to performance reviews.
• Participate in special projects and cross-functional initiatives as needed.

Key Competencies:

• Strong project management and multi-tasking capabilities.
• Team-oriented with the ability to operate effectively in matrix environments.
• Excellent written and verbal communication and presentation skills.
• High attention to detail and quality standards.
• Proactive problem-solver with sound decision-making ability.

Qualifications:

• Doctorate degree OR
• Master’s degree and 2 years of project management experience OR
• Bachelor’s degree and 4 years of project management experience OR
• Associate degree and 10 years of project management experience OR
• High school diploma/GED and 12 years of project management experience

Preferred Qualifications:

• Background in Life Sciences, Engineering, Supply Chain, or related fields.
• Experience managing change control systems in a GMP-regulated environment.
• Hands-on experience with SAP and Bill of Materials (BOM) management.
• Knowledge of regulatory affairs, quality systems, and deviation/non-conformance management.
• Familiarity with project tools such as Smartsheet, TrackWise (or equivalent), and MS Office.
• Excellent organizational, analytical, and communication skills.
• Proficiency in both English and Spanish (verbal and written).

Shift: Monday-Friday, 8 hours per day, Administrative shift