Inspection Readiness Lead

Position Overview

The Inspection Readiness Lead will be responsible for leading and executing GMP inspection readiness activities in support of a pre-approval / pre-licensing inspection. This role will serve as the primary driver for inspection preparedness at an externally outsourced manufacturing organization (CMO), ensuring systems, documentation, and subject matter experts are inspection-ready.

This is a hands-on, delivery-focused consulting role for an experienced quality professional who has directly led inspection readiness efforts and brings a clear, structured approach to execution, risk management, and stakeholder coordination.

Key Responsibilities

• Develop and lead a comprehensive GMP inspection readiness program for a pre-approval inspection conducted at a Contract Manufacturing Organization (CMO)

• Identify, assess, and mitigate inspection risks, including development of remediation plans and inspection storyboards for high-priority risk areas

• Plan, organize, and support mock inspections and readiness assessments

• Provide inspection training and coaching to subject matter experts

• Drive tactical inspection readiness activities, including readiness tracking and execution

• Develop and maintain inspection tools, communication plans, document request lists, and inspection governance structures

• Coordinate inspection readiness activities across internal teams and external partners, including CMOs

• Monitor health authority inspection trends and apply GxP expertise to proactively address compliance gaps

• Lead project management and reporting for the inspection readiness program, including:

  • Maintaining action, risk, and mitigation trackers
  • Driving follow-up and accountability with stakeholders
  • Providing monthly updates and progress reports to sr leadership

• Support quality system maturity initiatives as needed

• Author, review, and edit GMP documentation such as SOPs, forms, and supporting quality records

• Lead document comment resolution sessions and manage documentation workflows within an electronic QMS to meet inspection timelines

Required Qualifications

• Bachelor's degree in a science-related discipline

• 10 years of relevant experience in the biotech, pharmaceutical, or medical device industry

• Direct, hands-on experience leading GMP inspection readiness for pre-approval or pre-licensing inspections

• Strong understanding of GMP requirements and quality systems

• Demonstrated ability to lead inspection readiness efforts at externally outsourced manufacturing sites (CMOs)

• Strong project management skills with the ability to track activities, drive execution, and hold stakeholders accountable

• Excellent written and verbal communication skills, including sr leadership reporting

Preferred Experience

• Experience across clinical through commercial manufacturing stages

• Familiarity with FDA regulatory expectations (inspection experience strongly preferred but not required)

• Experience supporting GLP and GCP sponsor readiness and/or Pre-Licensing Inspections (PLI)

• Experience in gene therapy, cell therapy, or other complex manufacturing environments is a plus

Work Requirements

• Fully remote role

• Must be able to work with at least 6 hours of overlap with East Coast business hours

• Flexible scheduling available to support meetings and deliverables

Job Type & Location

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

Pay and Benefits

The pay range for this position is $110.00 - $140.00/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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Apr 27, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC---with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we work together at actalentservices.com.