Project Manager - GMP Quality

Contract Project Manager, Quality & Business Operations

Our client is seeking an experienced Contract Project Manager to lead the delivery of strategic business initiatives that support Quality, Compliance, and corporate operations within a regulated life sciences environment. This individual will be responsible for driving system implementations, process improvements, and cross-functional projects that enhance operational efficiency, compliance, scalability, and business performance.

The ideal candidate will have a strong project management experience coupled with direct exposure to GMP-regulated Quality functions. This role requires someone who can effectively partner with Quality, Regulatory, Finance, HR, Operations, and external vendors to deliver projects on time, within scope, and aligned with business and compliance objectives.

Key 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.

Required 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.

+ Ability to effectively interact with all levels of an organization, including sr leadership and external partners.

Preferred Qualifications

+ Experience supporting GxP-regulated environments.

+ Familiarity with 21 CFR Part 11, computerized system validation (CSV), change control, and Quality compliance requirements.

+ Experience partnering with Quality Assurance and Quality Systems teams.

+ PMP certification or equivalent project management credential.

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Experience with ERP, Quality Management, Document Management, Training Management, or other regulated business systems.

What We're Looking For

The successful candidate will be a collaborative, hands-on project leader who understands how to navigate a regulated environment while balancing business priorities, compliance requirements, and operational goals. Experience supporting GMP Quality functions and driving projects that impact Quality systems, compliance processes, and business operations is highly preferred.

Job Type & Location

This is a Contract position based out of Boston, MA.

Pay and Benefits

The pay range for this position is $90.00 - $110.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other…