Clinical Compliance, GCP Inspection Readiness

Job Title: Senior Manager, Clinical Compliance We are seeking a dedicated Senior Manager in Clinical Compliance to lead our GCP inspection readiness efforts. This role involves partnering with quality assurance and functional areas to define inspection focus and support readiness planning activities. The position offers a remote work arrangement with a preference for candidates in the Eastern time zone. Responsibilities Partner with QA and functional areas to define inspection focus areas and support inspection readiness planning activities. Manage study team inspection readiness deliverables, including storyboards, document preparation, and interview readiness. Lead and coordinate SME and functional area preparation activities, serving as the central point of coordination. Lead and manage process improvement initiatives, including the creation, enhancement, and revision of operational processes. Ensure strong alignment between functional workflows, SOP frameworks, and quality system requirements. Support functional areas in identifying SOP needs, authoring, reviewing, and performing periodic reviews. Identify training needs and support the development, authoring, and delivery of functional area training related to operational processes and quality expectations. Support internal and external issue management activities, including issue categorization, investigation participation, and deviation documentation. Guide study teams and functional areas in defining effective CAPAs and tracking CAPA completion. Partner with QA and other stakeholders to escalate quality events, potential serious breaches, and significant areas of concern through established escalation pathways. Essential Skills Bachelor's degree in Life Sciences, Pharmacy or a related scientific discipline. 8–10 years of experience in Clinical Quality Assurance, GCP Compliance, Clinical Operations, or related quality functions. 3–5 years of experience leading inspection readiness initiatives or quality projects. Experience supporting FDA and/or international regulatory inspections. Certified Quality Auditor (ASQ CQA), RQAP-GCP, or equivalent certification preferred. Extensive experience with global GCP inspection readiness programs and regulatory inspections. Strong understanding of ICH E6(R3) Good Clinical Practice, FDA GCP regulations, and applicable EU Clinical Trial Regulation. Additional Skills & Qualifications Experience with mock inspections and inspection simulations. Proficiency in inspection request management and logistics. Familiarity with Trial Master File (TMF) health checks and remediation. Knowledge of Quality Management Systems (QMS), CAPA development, and Root Cause Analysis. Ability to lead cross-functional project leadership and vendor qualification and oversight. Strong understanding of ALCOA+ principles, data integrity requirements, and Quality Risk Management principles (ICH Q9). Ability to facilitate inspection readiness meetings and working groups. Work Environment It provides the opportunity to lead GCP inspection readiness and collaborate closely with Senior leadership and cross-functional teams. Job Type & Location This is a Contract to Hire position based out of San Diego, CA. Pay and Benefits The pay range for this position is $90.00 - $100.00/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 Sep 18, 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.