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?
- Conducts and/or leads a variety of client-requested GCP audits (clinical sites globally), site inspection readiness visits and regulatory inspections support visits.
- Provides GCP consultation and support to project teams (GPHS) and external clients.
- Performs other types of client-requested QA audits or activities (e.g., documentation review, database audits, clinical study report audits, SOP development support).
- Leads QA related projects and prepares and presents audit findings and/or other related information at internal or client meetings.
- Serves as a knowledgeable resource to operational departments on audits or quality assurance subject matter.
- As requested by management, leads SSM investigations and supports Quality Events and Planned Deviations (GPHS)
Essential Functions and Other Job Information:
- Conducts and/or leads a variety of client, internal or GCP audits and regulatory inspections as requested by senior management
- Performs directed site audits, facility, vendor and/or sub-contractor audits
- Provides GCP 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)
- Serves as a knowledgeable 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
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 type 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/workloadValid 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 quality 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! 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.
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