Remote GMP Project Lead - Quality & Ops

Actalent; United States; Remote; USD 124,000 - 152,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Job summary

Actalent is seeking a Contract Project Manager to lead GMP-regulated Quality and Business Operations initiatives. You will drive cross-functional projects, system implementations, and process improvements in a heavily regulated life sciences environment.

The ideal candidate will have extensive project management experience within biotechnology or pharma settings, with strong collaboration across Quality, Regulatory, Finance, HR, and external vendors.

Qualifications

• Bachelor's degree or equivalent combination of education and relevant experience.
• 8+ years of project management experience within biotechnology, pharmaceutical, medical device, or other regulated life sciences industries.
• Strong experience leading cross-functional projects involving Quality, Compliance, and business operations.
• Demonstrated experience supporting GMP-regulated environments and Quality organizations.
• Working knowledge of Quality Management Systems (QMS), document control, CAPA, deviations, change control, training management, validation, and compliance processes.
• Experience driving process improvements and business transformation initiatives in a regulated setting.
• Proven ability to manage multiple projects simultaneously while balancing competing priorities and deadlines.
• Excellent communication, facilitation, stakeholder management, and organizational skills.

Responsibilities

• Lead the planning and execution of Quality and business operations projects from initiation through implementation.
• Develop and manage project plans, timelines, milestones, budgets, risks, and resource requirements.
• Partner with Quality, Regulatory, HR, Finance, and other business stakeholders to identify needs, define project scope, and establish priorities.
• Coordinate cross-functional teams to ensure project objectives are achieved efficiently and effectively.
• Manage system implementations, process enhancement projects, and operational improvement initiatives that support regulated business functions.
• Facilitate project meetings, stakeholder communications, status reporting, and issue resolution.
• Identify project risks, develop mitigation strategies, and proactively manage dependencies.
• Support change management, user adoption, training, and communication efforts to ensure successful implementation of new processes and systems.
• Maintain project documentation and ensure all deliverables are aligned with quality and compliance expectations.
• Monitor project budgets and resource utilization while driving cost-effective execution.
• Collaborate with external vendors, consultants, and business partners to support successful project delivery.
• Promote consistent project governance practices and ensure execution is audit-ready and well documented.

Skills

Project management

Cross‑functional leadership

GMP/regulatory exposure

Quality systems

Education

Bachelor's degree or equivalent

Tools

QMS software

Document control systems

ERP

Job description

Actalent is seeking a Contract Project Manager to lead GMP-regulated Quality and Business Operations initiatives. You will drive cross-functional projects, system implementations, and process improvements in a heavily regulated life sciences environment.

The ideal candidate will have extensive project management experience within biotechnology or pharma settings, with strong collaboration across Quality, Regulatory, Finance, HR, and external vendors.