**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** Thermo Fisher Scientific Inc. is a premier company that is dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are a team of 100,000+ colleagues who share a common set of values - Integrity, Intensity, Innovation, and Involvement. Together, we work to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. Due to the location of the clients for this role, the qualified candidate must live in the United States. This is a fully remote role. What will you do as a GCP Compliance Manager? Please read on to find out more. We would love to talk with you. **Essential Functions** : Provides project level QA support for multiple clients, working with internal and external teams. Activities can include quality event review, audit and inspection support, CAPA development, and attendance at team and client meetings to provide input and consultancy. Promotes awareness of quality and regulatory compliance standards and trends; participates in quality improvement activities. Leads all aspects of governance and compliance management processes; implements quality awareness objectives; develops and maintains quality and compliance guidance/reference materials and tools and provides any other support or knowledge necessary to advance the vision of the Global Quality and Compliance (GQ&C) group. **Education and Experience** : 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 5+ years’) or equivalent combination of education, training, & experience. **GCP experience is required** **Prior experience in a client facing role is required** **Thorough knowledge of applicable GxP and appropriate regional regulations is required** **Knowledge, Skills and Abilities** : **GCP experience is required** **Prior experience in a client facing role is required** **Thorough knowledge of applicable GxP and appropriate regional regulations is required** Extensive knowledge of the clinical trial process Expert knowledge of SOPs and WPDs Strong attention to detail Effectively works independently or in a team environment Highly developed problem-solving skills, risk assessment and impact analysis abilities Strong negotiation and conflict management skills Strong organizational and time management skills including ability to multitask and prioritize competing demands/workload Strong computer skills; ability to learn and become proficient with appropriate software Proven flexibility and adaptability Travel: 0-10% Some travel may be needed, however it should be minimal. **Our 4i Values:** Integrity – Innovation – Intensity – Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you! Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com (bolded) Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access (bolded) Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.