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Sr. Quality Lead

4 months ago

Rockville, United States Insight Global Full time

One of our large Pharmaceutical clients is seeking a Sr. Quality Lead to oversee and support an external manufacturer within Advanced Therapeutics in Rockville, Maryland (fully on-site role). In this role, you will be providing quality oversight for daily activities related to commercial operations supporting production of cell therapy products. Responsibilities include:

  • Acting as sponsor's representative and main point of contact for manufacturing decisions
  • Resolve manufacturing issues along with daily review of manufacturing investigations, change controls, deviations and out of specifications
  • Work to drive compliance to limit non-conformances
  • Perform reviews of batch records, procedures, documentation, and audits
  • Adhere with cGMP requirements along with general safety policies, implementing process improvements


Qualifications:

  • Minimum education level -- Bachelors degree in scientific field
  • 10+ years of experience working within quality manufacturing
  • Strong experience working with CMOs and in a GMP environment
  • Previous experience working on CAR-T, cell therapy or advanced therapeutic areas is preferred
  • Minimum 5 years of experience with Change and Deviation management -- ability to handle out of specifications


Pay: $70.00-$85.00/hr (flexible based on experience)

Hours: Monday-Friday, 8:00am-4:30pm

Hiring Method: Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year

PTO: 10 PTO days & 6 paid sick days annually

Benefits: Medical, Dental, Vision and 401K plans available


Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.