Specialist, Quality Management System

4 weeks ago

Vancouver, Canada AbCellera Full time

AbCellera is breaking the barriers of conventional antibody discovery to bring better medicines to patients, sooner. Our engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic with precision and speed.

The Specialist, Quality Management Systems (QMS) will be responsible for the overall design, implementation and management of our QMS for all AbCellera operations, including our state-of-the-art clinical manufacturing activities. In this role, based in Vancouver, Canada, you will bring your expert experience in the design of key quality processes and drive the implementation and continual improvement of our electronic QMS (eQMS). As the Specialist, QMS, you will also monitor the performance of the eQMS while supporting all cross-functional activities to ensure a culture of quality across the AbCellera organization.

**How you might spend your days**
- Establishing, designing, implementing, maintaining, and monitoring QMS framework processes (CAPA, Change, Deviation, Risk, Audit and Complaint Management) in close collaboration with the CMC/GMP team
- Creating and maintaining QMS policies, standards operating procedures and related documentation/records for the QMS functions/activities
- Designing and leading AbCellera's Quality Risk Management program following ICHQ9
- Continuously improving the QMS in a phase appropriate manner to gain agility, simplicity, efficiency, while preserving high quality standards and meeting contemporary global CMC/GMP requirements and expectations. This includes the implementation and improvement of an eQMS system.
- Overseeing the performance and effectiveness of the QMS programs, as well as supporting Quality Risk Management, Audit Management, Complaint Management, and Data Integrity, as needed
- Ensuring timely and accurate reporting via Quality Review Boards/Management Review on the performance of AbCellera's QMS, along with associated required improvements
- Supporting Health Authority inspections and partner audits and supporting drafting of follow-up responses for all aspects of the business
- Collaborating with training teams to provide insight and guidance on the planning and implementation of quality system related training to ensure a closed loop within all QMS activities

**We'd love to hear from you if**
- You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
- You are passionate about building dynamic new teams and capabilities that accomplish important goals
- You have a bias towards innovation over industry standards
- You have the ability to anticipate and resolve problems effectively
- You are an outstanding communicator and teammate and you lead by example

**Required Qualification and Experience**
- A Bachelor or Master's degree in a relevant scientific discipline and 5+ years of industry experience within the quality organization in biotechnology, the pharmaceutical industry, or life sciences
- 5+ years of quality system management experience in a GxP regulated environment
- Profound hands-on experience in Quality Risk Management as defined in ICHQ9
- Experience in GMP manufacturing for biologics, including aseptic technique/operations, environmental monitoring programs, and media simulation studies
- A thorough understanding of the drug development processes from discovery through CMC development, with an ability to understand business requirements and translate them into practical quality systems solutions
- Results oriented, and able to effectively execute on projects with mínimal supervision
- Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment
- Strong computer skills electronic Quality Management Systems (e.g. eQMS, QRM e-system, eDMS, eLMS)

**What we offer**:
AbCellera's hiring range for this role is $80,000 - 100,000 CAD annually, commensurate with your education and job-related knowledge, skills, and experience. We base our salary ranges on localized market data ensuring competitive compensation. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.

We have a number of ways to support AbCellerites in maximizing their work-life synergy. You will have a $1,500 annual Active Lifestyle Allowance, annual vacation, the opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you'll find abundant teams and social groups to build community and connections across AbCellera.

**About AbCellera**:
At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation,

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