Compliance Manager, Quality Oversight Lead-- fully remote!
Thermo Fisher ScientificAbout the role
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, and supporting our customers’ medical related inquiries. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
What will you do in this role?
Be a dedicated, single point of Quality contact for client
Partners with Ops to establish a consistent Quality culture across the studies or portfolio
Attend regular partnership level and ad hoc team meetings
Provide direction and recommendation for issue avoidance
Continuous awareness and periodic review of QE/SSM/SB/sPIP/Audit/ Inspections
Escalate appropriately to Client Quality/Quality Partner/DevOps/bPL/PDL to minimize client impact and improve outcomes
Qualification Requirements:
Education Requirements:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
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.
Experience requirements:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, & experience.
Working knowledge of GCP is required.
Experience in a client facing role is required.
Strong presentation skills and professional client communication capabilities is required.
Experience working with either Clinical Trial Management, Project Management, Quality Assurance and/ or Quality Management is required.
Experience working with cross functional, inter-departmental collaboration and stakeholder management is required.
Knowledge, Skills and Abilities:
Extensive knowledge of the clinical trial process
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.
Location: Fully remote. Relocation assistance is NOT provided.
*Must be legally authorized to work in the US without sponsorship.
*Must be able to pass a comprehensive background check, which includes a drug screening.
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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sex
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