Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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 do in this role?
- Conduct and/or lead a variety of client-requested GCP audits (clinical sites globally), site inspection readiness visits and regulatory inspections support visits.
- Provide GCP consultation and support to project teams (GPHS) and external clients.
- Perform other types of client-requested QA audits or activities (e.g., documentation review, database audits, clinical study report audits, SOP development support).
- Lead QA related projects and prepare and present audit findings and/or other related information at internal or client meetings.
- Serve as a knowledgeable resource to operational departments on audits or quality assurance subject matter.
- As requested by management, lead SSM investigations and support Quality Events and Planned Deviations (GPHS).
Essential Functions and Other Job Information:- Conduct and/or lead a variety of client, internal or GCP audits and regulatory inspections as requested by senior management.
- Perform directed site audits, facility, vendor and/or sub-contractor audits.
- Provide GCP consultation and support to project teams and external clients.
- Lead process audits and may participate as a co-auditor in more complex system audits.
- Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement).
- Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter.
- Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings.
Qualifications:Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
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:- Thorough knowledge of GCP and appropriate regional research regulations and guidelines.
- Knowledge in GxP guidelines recommended.
- Demonstrated proficiency and led a range of project based GCP audits to clinical sites to high standards required by management.
- Proficiency in other types of audits (process, database, clinical study report, vendors) recommended.
- Excellent oral and written communication skills.
- Strong problem solving, risk assessment and impact analysis abilities.
- Solid experience in root cause analysis and CAPA implementation.
- Above average negotiation and conflict management skills.
- Flexible and able to multi-task and prioritize competing demands/workload.
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel.
Travel requirements:This role will involve 50-75% travel, both domestic & international. If you are not willing to travel this much, unfortunately you will not qualify for this role.
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!
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: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.
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