Senior Compliance Manager GCP Process Lead FSP

Work Schedule

Environmental Conditions

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-timeguidanceon 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:

Bachelors 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 of6 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

• Bachelors 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 drivers license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

• Domestic/internationaltravel (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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.