MA: Sr Consultant GMP QA Operations (232246)

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Job Description:

Our MA client needs a Quality GMP consultant in Massachusetts to support their Cell & Gene Therapy product line. This is role is going to be centered around Clinical manufacturing for exosomes, and due to the fact that there are no current regulations around exosome manufacturing, this candidate will need to take a risk based approach when making decisions for the GMP manufacturing. Biotech experience required; Cell & Gene Therapy preferred (no small molecule/pharma). This is a very dynamic role as the day to day will change, but candidate can expect to be reviewing and executing batch records, fielding questions from internal teams, manage vendors, join project team calls with CMOs and contract testing orgs, getting involved in deviations, etc. They need this person to have at least 7-10 years of experience and to be within commutable distance from the site for when onsite troubleshooting is necessary. Additional experience with auditing, training management, and quality systems (managing, training, and creating trace matrices) is preferred. They currently use Zen QMS and Sharepoint as their main systems.

Skills:

GMP, risk based, Cell & Gene Therapy, Biotech, quality systems management

Education:

experience outweighs degree

MA: Sr Consultant GMP QA Operations (232246)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
State
Massachusetts

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