Quality Oversight Lead- fully remote!

Thermo Fisher Scientific • Wilmington, NC

16d • 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? Be a d edicated, single point of Quality contact for client Par tners with Ops to establish a consistent Quality culture across the studies or portfolio Attend regular partnership level and ad hoc team meetings Pro vide direction and recommendation for issue avoidance Con tinuous awareness and periodic review of QE/SSM/SB/ sPIP /Audit/ Inspections Es calate appropriately to Client Quality/Quality Partner/DevOps/ bPL /PDL to minimize client impact and improve outcomes

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.
• 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
• Proven flexibility and adaptability
• 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

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees