Apply on Employer Site

Thermo Fisher Scientific · 1 day ago

Quality Oversight Lead- fully remote!

United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

Thermo Fisher Scientific is a leading company committed to enabling customers to make the world healthier, cleaner, and safer. The Quality Oversight Lead will act as a primary Quality contact for clients, ensuring a consistent Quality culture across studies, and providing recommendations for issue avoidance while collaborating with various teams.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

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

GCPClient Facing ExperienceClinical Trial ManagementQuality AssuranceProblem-Solving SkillsNegotiation SkillsOrganizational SkillsAttention to DetailTime Management

Required

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

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

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