GCP Project Manager

Job Title: Senior Project Manager – Inspection Readiness and Operational Excellence

This role leads complex, cross-functional initiatives that support inspection readiness, commercial readiness, remediation planning, and operational excellence within a regulated life sciences environment. You will develop and manage integrated project plans, drive execution across multiple functions, and ensure that all deliverables meet quality, compliance, timeline, and business expectations. This position offers the opportunity to work on high-visibility, business-critical programs while shaping governance routines and improving processes that enable sustainable quality and operational outcomes.

Responsibilities

• Develop and manage integrated project plans that include detailed timelines, milestones, dashboards, action logs, risk registers, and executive-level status updates.
• Lead cross-functional teams across Quality, Regulatory, Manufacturing, Supply Chain, Clinical, Commercial, Technical Operations, and related functions to drive project execution.
• Drive inspection readiness activities by leading readiness planning, coordinating evidence preparation, supporting mock inspections, tracking issues, and managing follow-up actions.
• Coordinate and facilitate GCP inspection readiness activities by developing inspection readiness plans, tracking cross-functional deliverables, coordinating evidence and document requests, supporting mock inspections, and monitoring action items, risks, and dependencies.
• Collaborate with Quality, Clinical Operations, Regulatory Affairs, and other functional teams to ensure timely completion of inspection-related follow-up activities.
• Support commercial readiness by coordinating operational, quality, supply, documentation, training, process, and launch-related workstreams to enable successful product or program launches.
• Oversee remediation plans related to audit findings, inspection observations, quality events, CAPAs, process gaps, and operational deficiencies, ensuring effective closure and sustainable improvements.
• Establish and maintain governance routines, including decision forums, reporting mechanisms, and escalation pathways, to promote transparency, accountability, and timely decision-making.
• Manage project risks, issues, dependencies, and decisions, ensuring clear communication and alignment with Senior stakeholders and cross-functional leaders.
• Prepare and deliver clear, concise, and insightful executive-level communications and status reports that highlight progress, risks, and required decisions.

Essential Skills

• Bachelor’s degree in Life Sciences, Engineering, Business, Operations, Quality, Regulatory Affairs, or a related discipline.
• 8 years of project management experience in a regulated life sciences, pharmaceutical, biotechnology, medical device, or healthcare environment.
• Proven experience managing complex, cross-functional projects with compliance-driven deliverables and competing priorities.
• Demonstrated experience working on projects with Senior stakeholder visibility and engagement.
• Strong understanding of GxP principles and quality systems within regulated environments.
• Hands-on experience with inspection readiness activities, including planning, evidence preparation, mock inspections, and follow-up actions.
• Experience with CAPA management, audit support, and remediation execution.
• Strong ability to manage project plans, timelines, risks, decisions, communications, and executive-level reporting.
• Proficiency with Microsoft Office, including tools such as Word, Excel, PowerPoint, and related productivity applications.
• Proficiency with project management tools used to track timelines, deliverables, risks, and status.

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

The pay range for this position is $100.00 - $110.00/hr.

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)

This is a fully remote position.

This position is anticipated to close on Jul 17, 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 actalentaccommodation@actalentservices.com 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.

Salary : $100 - $110