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Senior Manager QA, cGMP and GDP

Company: EQRx
Location: Cambridge
Posted on: September 16, 2020

Job Description:

As our Senior Manager QA, cGMP and GDP you will execute batch record reviews and batch dispositions of Drug Substance and Drug Products. You will review executed clinical labeling batch records and perform product disposition of API and Finished Goods. You will review/approve clinical labels for use and perform quality review of stability analytical data and reports. You will contribute to vendor management programs by evaluating questionnaires, audit reports and risk assessment documents for manufacturers, analytical laboratories, and other vendors. You will review manufacturing, analytical and supply chain deviations and investigations and review OOS/OOT investigations.

You will act as the quality approver/assessor for Change controls and oversee generation and review of documents used in cGMP & GDP activities such as Quality Agreements, COAs, analytical validations/transfers, process validations, master & executed batch records, label proofs, specifications and change controls. You will be the lead QA representative on CMC project teams with Contract Manufacturing Organizations (CMOs) and Contract Labs. You will provide QC support including lab inspections, method qualification, method technology transfer, etc. You will review and approve discrepancy reporting, investigations and CAPAs associated with incoming, in process and production batch processing, release and stability testing, and product complaints.

You will contribute in a supporting role to cGMP (Current Good Manufacturing Practice) & GDP (Good Distribution Practice) PAI (Pre-Approval Inspection) and associated commercial launch readiness initiatives. You will lead the quality review of CMC sections in regulatory applications and contribute in a supporting role during partner due diligence activities and regulatory inspections. You will be responsible for identification and monitoring of Key Process Indicators (KPIs) for reporting of Quality Metrics. You will contribute to the development of SOPs, other controlled documents, and training courseware for cGMP & GDP Quality Assurance. You will initiate QA deviations and CAPAs and perform investigations and root cause analysis with oversight from QA Management. You will provide quality oversight of contract activities as needed and track and coordinate follow up of GMP audit corrective and preventative actions at the contract sites. You will also be responsible for coordinating the GMP vendor qualification process.

The Impact You will Have This is not your standard QA Manager position. This role is a highly visible position and of significant impact to the company and to the success of our programs. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.

Who You Are You have a BA/BS, ideally in a scientific discipline.

You have a minimum of 10 years of relevant experience in a regulated environment with at least 6 years focused on product quality.

You have strong knowledge of global cGMP & GDP regulations and guidance.

You have experience working with CDMOs.

You have a working knowledge of ICH/GxP regulations and expectations.

You understand and can use problem solving tools such as Risk Analysis, Root Cause Analysis and FMEA.

You have strong knowledge of bulk and finished product manufacturing and analytical testing.

You are an excellent communicator.

You are goal and timeline driven.

You have strong technical expertise in QA/QC, Manufacturing, and Supply Chain processes supporting development and maintenance of cGMP compliant quality systems.

You can participate and work effectively on multiple cross-functional teams.

You understand relationships are key and have strong interpersonal skills.

You can thrive in a smaller company environment and love the pace of a true startup.

You’re a team player who is willing to roll-up your sleeves and get the job done.

EQRx is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Keywords: EQRx, Cambridge , Senior Manager QA, cGMP and GDP, Other , Cambridge, Massachusetts

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