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
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
You have a minimum of 10 years of relevant experience in a
regulated environment with at least 6 years focused on product
You have strong knowledge of global cGMP & GDP regulations and
You have experience working with CDMOs.
You have a working knowledge of ICH/GxP regulations and
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
You understand relationships are key and have strong
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.