What are the responsibilities and job description for the Process/CQV Project Manager position at ELIQUENT Life Sciences?
About Company:
Who Are We?
ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.
Why explore your future at ELIQUENT?
ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.
About the Role:
The Project Manager will lead and oversee complex projects within the professional, scientific, and technical services industry, ensuring all objectives are met on time, within scope, and budget. This role is pivotal in managing projects that involve Good Manufacturing Practices (GMP), process validation, commissioning, and process engineering activities. The successful candidate will coordinate cross-functional teams, manage project schedules, and maintain rigorous documentation to comply with industry standards and regulatory requirements. They will serve as the primary point of contact for stakeholders, facilitating communication and resolving issues to drive project success. Ultimately, the Project Manager will deliver validated, compliant, and efficient processes that support organizational goals and client satisfaction.
Minimum Qualifications:
- Bachelor’s degree in Engineering, Science, or a related technical field.
- Proven experience managing projects within GMP-regulated environments.
- Strong knowledge of process validation and commissioning principles.
- Proficiency in Microsoft Project for project scheduling and tracking.
- Excellent organizational, communication, and leadership skills.
Preferred Qualifications:
- Project Management Professional (PMP) certification or equivalent.
- Experience in process engineering within pharmaceutical, biotech, or related industries.
- Familiarity with advanced project management tools and software.
- Knowledge of regulatory requirements such as FDA or EMA guidelines.
- Experience working in a professional, scientific, and technical services environment.
Responsibilities:
- Develop, implement, and maintain detailed project plans and schedules using Microsoft Project to ensure timely delivery of project milestones.
- Coordinate and lead cross-functional teams including engineering, quality assurance, and operations to execute process validation and commissioning activities.
- Ensure all project activities comply with Good Manufacturing Practices (GMP) and relevant regulatory standards.
- Manage project risks, issues, and changes proactively, communicating status updates and progress to stakeholders regularly.
- Oversee documentation and reporting for process validation and commissioning to support audit readiness and regulatory submissions.
Skills:
The required skills such as Good Manufacturing Practices (GMP), process validation, and commissioning are applied daily to ensure that all project deliverables meet stringent quality and regulatory standards. Project coordination and planning skills are essential for developing comprehensive project schedules and managing resources effectively using Microsoft Project. Process engineering knowledge supports the technical evaluation and optimization of manufacturing processes throughout the project lifecycle. Strong communication and leadership skills facilitate collaboration among diverse teams and stakeholders, ensuring alignment and timely resolution of issues. Preferred skills like PMP certification and familiarity with regulatory guidelines enhance the ability to manage complex projects with greater efficiency and compliance assurance.