Quality Oversight Lead-- fully remote!

Thermo Fisher Scientific•Wilmington, NC

1d•Remote

About The Position

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? To provide Clinical Quality oversight and support to the clinical study teams. To pro-actively implement quality principles during the clinical design and set-up, study conduct, and reporting, providing continuous support and input during the Clinical Development Activities in the GCP area. Provides Quality principles and quality insights to the study team at study design and start up. Acts as the first point of contact for any quality related questions/ concerns for study teams. Owns the Quality role on study level by providing continuous quality compliance support and by acting as an internal advisor to the study team on relevant processes, procedural documents, and regulations to ensure correct interpretation and implementation. Ensures alignment with client quality and the quality agreement, and is the conduit to consult with the client on study quality issues and investigational strategies to ensure transparency of direction. Leads the quality oversight for assigned clinical studies in close collaboration with the study team. Provides guidance to the clinical study team to ensure clinical studies are executed and compliant to GCP and local regulatory requirements. Supports the design of study risk management plans and the definition of appropriate risk responses + QTLs; helps to mitigate quality compliance risks. Coordinates and supports in GCP audits as needed with the appropriate partnership role to ensure audit focus and scopes are determined correctly at study level and to ensure GCP compliance throughout the study and audits are assigned on a risk-based level. In close collaboration with client quality staff escalates quality / compliance / privacy issues and supports investigation and definition of necessary corrective and preventive measures. In close collaboration with client quality staff and per procedure contributes to the assessment, evaluation, and investigation of any (potential) serious breaches. Leads, in collaboration with study teams, inspection readiness activities and participates in inspections as defined by the client, in collaboration with internal study teams.

Requirements

Bachelor's degree is 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.
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.
Proven experience in building strong relations is required.
Experience working with CRO and/or Pharma companies is required.
Ability to co-exist in 2 organizations and navigate organizational structures and dotted line reporting line(s) to achieve clear communication and transparency.
In‐depth knowledge of all Clinical Trial related FDA and EU regulations and ICH Guidelines.
Current and strong knowledge of Clinical Development processes according to Good Clinical Practices (GCP) and regulatory requirements.
Ability to motivate and educate the clinical study team on clinical quality aspects.
Capable of building effective relationships with internal and external stakeholders.
Ability to translate quality culture and ways of working to study teams.
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.

Responsibilities

To provide Clinical Quality oversight and support to the clinical study teams.
To pro-actively implement quality principles during the clinical design and set-up, study conduct, and reporting, providing continuous support and input during the Clinical Development Activities in the GCP area.
Provides Quality principles and quality insights to the study team at study design and start up.
Acts as the first point of contact for any quality related questions/ concerns for study teams.
Owns the Quality role on study level by providing continuous quality compliance support and by acting as an internal advisor to the study team on relevant processes, procedural documents, and regulations to ensure correct interpretation and implementation.
Ensures alignment with client quality and the quality agreement, and is the conduit to consult with the client on study quality issues and investigational strategies to ensure transparency of direction.
Leads the quality oversight for assigned clinical studies in close collaboration with the study team.
Provides guidance to the clinical study team to ensure clinical studies are executed and compliant to GCP and local regulatory requirements.
Supports the design of study risk management plans and the definition of appropriate risk responses + QTLs; helps to mitigate quality compliance risks.
Coordinates and supports in GCP audits as needed with the appropriate partnership role to ensure audit focus and scopes are determined correctly at study level and to ensure GCP compliance throughout the study and audits are assigned on a risk-based level.
In close collaboration with client quality staff escalates quality / compliance / privacy issues and supports investigation and definition of necessary corrective and preventive measures.
In close collaboration with client quality staff and per procedure contributes to the assessment, evaluation, and investigation of any (potential) serious breaches.
Leads, in collaboration with study teams, inspection readiness activities and participates in inspections as defined by the client, in collaboration with internal study teams.