Senior QC Data Reviewer

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.

We're looking for an experienced QC Data Reviewer to support internal and external GMP testing across our clinical development programs. In this role, you'll provide independent review of analytical and microbiological data generated for release, stability, raw material, validation, qualification, and method transfer activities. You'll make sure every result is accurate, traceable, and compliant with approved methods, specifications, protocols, SOPs, and GMP requirements, with data integrity at the centre of your work.

With a significant volume of QC activity ahead across multiple projects, your reviews will keep data moving and support timely product disposition. If you're a detail-driven QC professional who wants your work to directly help get clinical programs to the patients who need them, we'd love to hear from you.

• Performing independent GMP review of analytical and microbiological data from internal QC laboratories and external testing partners, covering release, stability, raw material, in-process, drug substance, drug product, and placebo testing across techniques such as HPLC/UPLC, GC, UV/Vis, spectroscopy, wet chemistry, bioburden, endotoxin, environmental monitoring, and utilities testing
• Reviewing raw data, calculations, chromatograms, spectra, instrument outputs, worksheets, and laboratory records for accuracy, completeness, traceability, and compliance with approved methods, specifications, protocols, SOPs, and GMP requirements
• Verifying calculations, sample identification, acceptance criteria, and reported results, and escalating OOS, OOT, atypical results, trends, deviations, and other data irregularities
• Ensuring laboratory data and records meet ALCOA+ data integrity expectations, including review of electronic records and audit trails
• Reviewing data and reports for method development, qualification, validation, verification, and transfer activities, along with instrument and equipment qualification, calibration, and preventive maintenance records, and supporting completion of final study packages
• Partnering with analysts and scientists to resolve documentation gaps, corrections, and incomplete testing in a timely and compliant manner
• Providing technical review and scientific judgment in support of deviations, investigations, OOS/OOT assessments, root cause analysis, and CAPAs
• Reviewing Certificates of Analysis, stability reports, and other controlled QC reports to support timely data release in line with program and manufacturing timelines
• Supporting the preparation of analytical and microbiological content for regulatory submissions, providing QC support to program and CMC sub-teams, and contributing to the development and revision of QC SOPs, forms, templates, and work instructions
• Driving continuous improvement in QC processes, data integrity, and reviewer practices by identifying recurring issues, coaching analysts and scientists on good documentation practices, and contributing to inspection and audit readiness

• You have a Master's degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Life Sciences, or a related scientific field, with 5+ years of relevant GMP experience in pharmaceutical or biotechnology QC (a Bachelor's degree with significant additional relevant experience will also be considered)
• You have hands-on experience in a GMP laboratory, including independent QC data review, with a strong ability to review analytical data from techniques such as UPLC, UV/Vis, ELISA, CE-SDS, iCIEF, spectroscopy, and wet chemistry (microbiology data review is an asset)
• You have experience reviewing release, stability, method validation/qualification/verification, and method transfer data
• You have strong knowledge of GMP, ALCOA+ data integrity principles, OOS/OOT, deviations, investigations, CAPA, and change control
• You are comfortable working with laboratory systems such as Empower and LIMS
• You critically evaluate analytical data to identify discrepancies, trends, documentation gaps, and issues that need escalation
• You are detail-oriented and organized, managing multiple priorities against release, stability, manufacturing, and regulatory timelines
• You communicate clearly,…