**Work Schedule** Standard Office Hours (40/wk) **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. What will you be doing in this role? Leads complex and/or multi-department internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting quality and/or regulatory compliance, determines root cause of non-conformance and develops strategies to address issues. May perform technical document review and other GxP activities in support of project work or company process. Provides finished audit reports to management. Plans and delivers billable quality services for clients and projects and may serve as the client contact. **Essential Functions:** + Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management + Leads directed site audits, facility, vendor and/or sub-contractor audits + Provides GxP consultation and support to project teams and external clients + Leads process audits and may participate as a co-auditor in more complex system audits + Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement) + Contacted by others to serve as a resource to operational departments on audit or quality assurance subject matter + Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings + Provides mentorship and guidance to junior auditors **Degree and experience requirements:** Bachelor's degree with 5+ years of related experience Experience with GxP auditing required Experience with SDLC required Experience with Quality management systems required Experience with Information Security preferred Experience with Part II Compliance required 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. Knowledge, Skills and Abilities: •Detailed knowledge of GxP and appropriate regional research regulations and guidelines • Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management • Excellent oral and written communication skills • Strong problem solving, risk assessment and impact analysis abilities • Solid experience in root cause analysis • Above average negotiation and conflict management skills • Flexible and able to multi-task and prioritize competing demands/work load • Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel **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.