Senior Compliance Manager - GCP Process Lead - FSP

Thermo Fisher Scientific•Wilmington, NC

1d•Onsite

About The Position

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.

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.
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
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
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

Nice To Haves

Preferred experience with inspection preparation, including hands on regulatory inspection activities
Bachelor’s degree preferred or commensurate with experience

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