Senior Compliance Manager - GCP Process Lead - FSP

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Compliance Manager - Make an Impact at the Forefront of Innovation The Senior Compliance Manager identifies, develops and executes quality and compliance strategies and initiatives across the organization, including promoting awareness of advanced quality and regulatory compliance standards and trends. This role leads and/or reviews complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. The Senior Compliance Manager performs technical document review and other GCP practice activities in support of clinical development programs. Additionally, oversees governance and compliance management processes; develops and leads quality and compliance guidance/reference materials and tools, and provides expertise to advance the vision of the department. Key Responsibilities Facilitate and manage cross-functional teams' GCP inspection readiness activities throughout the study lifecycle. Embed real-time inspection readiness strategies into daily operations, collaborating with study teams. Provide just-in-time guidance on key operating model processes and required documentation, prioritizing real-time inspection readiness. Manage and guide teams on inspection readiness planning, developing and maintaining readiness plans and tools. Facilitate the development of key inspection deliverables, including functional presentations and study team preparation for audits. Ensure high-quality deliverables for global studies by guiding adherence to operational processes and documentation. Champion proactive prioritization of inspection readiness, focusing on GCP process excellence. Engage with subject matter experts in inspection readiness activities and study-level risk assessments. Coordinate and manage TMF performance and processes, ensuring compliance and inspection readiness. Lead and participate in meetings for assigned projects, ensuring effective communication and addressing customer concerns. Maintain project management documentation, including plans, timelines, and progress reports. Coordinate activities to enable study team readiness for internal audits and regulatory inspections. Manage functional teams during inspections, collaborate with SMEs, and ensure timely follow-up

Education & Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years') or equivalent combination of education, training, & experience. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Qualifications Good understanding of clinical trial processes related to sponsor and CRO activities, including but not limited to sponsor oversight, issue management, site management, and clinical monitoring Preferred experience with inspection preparation, including hands on regulatory inspection activities Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field; with at least two years specifically supporting clinical Quality & Compliance Prior experience in Clinical Trial Conduct as (PM, CTM, CRA, CTA). Solid knowledge of drug development, clinical trial management, and/or GCP compliance processes Proven awareness of sponsor oversight requirements and regulations Experience with CROs and outsourced clinical trial activities, sponsor experience preferred Experience in problem solving, negotiations, and collaborative team building and other collaborators is required Strong understanding of regulatory requirements within clinical trials, industry standards, and related documentation needs Bachelor's degree preferred or commensurate with experience Must be able to efficiently apply computer software programs like Microsoft Office for general use, project management, and presentations Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel Domestic/international travel (5-20%) may be required Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow's breakthroughs. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.