Senior Manager, QA for QC
AbCellera is breaking the barriers of conventional antibody drug discovery to bring better medicines to patients, sooner. AbCellera’s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.
We are searching for an experienced Quality Assurance (QA) Sr. Manager to oversee the review and disposition of all data generated from the cGMP Quality Control (QC) labs supporting AbCellera’s state-of-the-art Biologics Drug Substance (DS) and Drug product (DP) Clinical Manufacturing facility. As the responsible QA Manager overseeing all QC Laboratory activities, you will play an important role in ensuring that our processes and procedures meet the highest standards of quality and compliance.
We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!
We’d love to hear from you if
- You are someone who is enthusiastic about adopting innovative approaches that enable agile, sustainable compliance.
- You have experience leading, overseeing, participating, and executing QA for QC activities
- You are comfortable and work well within cross-functional teams providing oversight and support in an evolving, complex, and dynamic environment
How you might spend your days
- Developing and supporting the development of all departmental processes, documents/procedures and records needed for QA of QC related operations.
- Reviewing and disposition of all manual and electronic data associated with the testing of incoming Materials/Components, Environmental/Clean Utilities, in-process testing of bulk DS/DP, FDP testing, Stability programs, Retention/Reference samples, Reference Standards/Materials, and Cell Banking activities.
- Reviewing and disposition of data generated by Third Party Laboratories on behalf of AbCellera.
- Reviewing and approval of protocols and reports related to QC equipment and/or instrumentation qualification and validation, QC method transfers, and QC Method Verification/Qualification/Validation
- Reviewing and approval of ongoing monitoring reports, such as EM and Utility Trending, APQRs, QC Method Monitoring, etc.
- Documenting and escalating issues related to QC data, including errors, inconsistencies, non-compliance, and data suspected or confirmed to be out of trend (OOT) or out of specification (OOS). Review and disposition of QC data conducted during investigations and product complaint investigations.
- Documenting and escalating all Data Integrity issues and/or other non-conformances identified during the review of QC data and reports.
- Providing QA support towards ensuring the timely completion of all commitments generated by observations of regulatory agencies and audits of the cGP QC labs.
- Supporting the compilation and review of QC generated data to be used for Regulatory Submissions (e.g. IND/CTA) and partnering activities. Support the generation of responses to official requests for additional information.
- Maintaining a strong working knowledge of relevant compendia, regulatory standards, and guidance and QC instrumentation and operations.
- Providing accurate and timely updates of metrics to QC/QA management, including trending of QC data errors.
- Managing QA of QC reviewers as necessary.
Requirements & Qualifications
- Bachelors or Master’s Degree in an applicable science and 8+ years of relevant QC and QA experience.
- Strong knowledge of QC and QA operations, QC instrumentation, electronic systems and data formats.
- Strong knowledge and understanding of data integrity requirements and knowledge of manufacturing and testing requirements of biological products.
- Working or educational knowledge of cGMP, USP, ICH, EP and FDA guidelines.
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