Biostrategenix LLC · 5 days ago
Senior Project Manager
Worcester, MA
Full-time
Onsite
Senior LevelBiostrategenix LLC focuses on simplifying quality compliance through lean principles, providing scalable systems for global regulatory standards. They are seeking an experienced Senior Project Manager to manage engineering/automation/CSV related projects, ensuring timelines, budgets, and quality standards are met while leading cross-functional teams.
Management Consulting
Responsibilities
Gather required project plan inputs then develop, maintain and execute the cross-functional project plan. Track and hold team accountable for measurable actions
You might manage implementation across multiple sites
Manage change control, deviation documentation and timelines and validation/compliance packages
Maintain 100% compliance with project timelines, regulatory agencies, functional systems, ethics policies and project goals
Identify and anticipate schedule changes and their impact to scope and deliverables
Present project status to management and stakeholders at scheduled management update meetings and client steering meetings
Develops team charter, implementation plans, conducts risk assessments and develops and implements contingency plans to accommodate unforeseen events and changes in strategy
May be responsible for indirect and/or direct management of contract coordinator and/or associated project management staff including workload management, quality deliverables, and escalation of issues to management when needed
Qualification
Required
Strong expertise in Engineering related Project Management for pharmaceutical/ biopharmaceutical organizations, with the ability to plan, execute, and ensure the successful completion of projects
Hands on experience with GxP, 21 CFR Part 11/Annex 11 requirements and eQMS software like (MasterControl/Veeva)
Skills in supporting Inspections and monitoring compliance with quality standards and regulatory requirements
Excellent communication, leadership, and organizational skills, with a results-oriented mindset
Bachelor's degree in a relevant field such as Engineering, Business Management, or a related discipline
Experience in biopharmaceutical/pharmaceutical industry
Proficiency with project management tools and methodologies is a strong advantage
Company
Biostrategenix LLC
At Biostrategenix, we believe that simplicity is the key to quality compliance.
Founded in 2025
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase