*This is a year long contract position with strong potential for extentions or permanent hire*

Required Skills and Experience *

-Minimum education level -- Bachelors degree in scientific field

-10 years of experience working within external quality manufacturing

-Strong experience working with CMOs

-Previous experience working on CAR-T, cell therapy or advanced therapeutic areas

-Strong in Root Cause Analysis in a Pharmaceutical environment

-Minimum 5 years of experience with Change and Deviation management -- ability to handle out of specifications

-Ability to work independently

-Strong interpersonal and written/oral communication skills

-Ability to quickly process complex information and make critical decisions with limited information in a complex and time-sensitive environment

Job Description *

Our large Pharmaceutical client is seeking a Senior Quality Lead to oversee and support an external manufacturer within Advanced Therapeutics in Rockville, Maryland. In this role, you will be providing quality oversight for daily activities related to commercial operations supporting production of cell therapy products.

Responsibilities will 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

Compensation :

$65/hr to $80/hr.

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.