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 May 25, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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.