Project Manager - GMP Quality

Actalent; Boston (MA); Remote; USD 124,000 - 152,000; Full time

Job summary

Actalent is seeking a Contract Project Manager to lead Quality and Business Operations initiatives in a regulated life sciences environment. You will drive system implementations, process improvements, and cross-functional programs with Quality, Regulatory, Finance, HR, and Operations.

The role requires 8+ years in project management within biotech/pharma, and experience with GMP-regulated quality functions. This contract position is fully remote with Boston-based presence for coordination.

Qualifications

• 8+ years in project management within regulated life sciences.
• Experience with GMP, Quality, and cross-functional programs.
• Strong communication, planning, and risk management skills.
• Familiar with QMS, document control, CAPA, deviation handling.
• PMP or equivalent certification preferred.

Responsibilities

• Lead planning and execution of Quality and business operations projects.
• Develop project plans, timelines, budgets, risks, and resources.
• Coordinate with Quality, Regulatory, HR, Finance and partners.
• Manage system implementations and process improvement projects.
• Facilitate meetings, status updates, and issue resolution.
• Identify risks and driving mitigation strategies.
• Support change management and user training for new processes.
• Ensure audit-ready documentation and governance.

Skills

GMP experience

Cross-functional leadership

Stakeholder management

Budget management

Risk management

Education

Bachelor's degree

Tools

QMS

Document Control

CAPA

Validation

Change control

Job description

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.
• 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 pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 9, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.