Manager, Quality Systems

2 weeks ago

Vancouver, Canada AbCellera Full time

AbCellera is an energetic, and rapidly growing tech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. Working at the interface of computation, engineering, and biology, AbCellera is rebuilding the front-end process of how drugs are discovered with a discovery platform that integrates modern technologies from engineering, microfluidics, single-cell analysis, high-throughput genomics, machine learning, and hyper-scale data science. With over 400 AbCellerites and growing, we're expanding our capabilities to include CMC development and GMP manufacturing of antibodies to bring therapies from idea to patients, faster.

The Manager, Quality Systems (QS) will be responsible for supporting the overall design, implementation and management of the Quality Management System (QMS) for CMC/GMP activities, including the performance and execution of the QMS framework within Abcellera, ensuring compliance with global regulations and standards set forth by governing regulatory and accrediting agencies. The role will be responsible to monitor the health of the QMS for continuous improvement, while supporting cross-functionally to help ensure a culture of quality across the CMC/GMP organization. You will be given the freedom to innovate and move at lightning speed to create a legacy in our industry.

**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

**How you might spend your days**
- Establishing, supporting, maintaining, monitoring QMS framework processes and robust quality systems management program in compliance applicable global CMC/GMP requirements
- Creating, and executing QS plans and reports for CMC/GMP activities
- Leading the management of Quality System execution, including Deviation, CAPA, Change Control, Complaints, as applicable
- Creating and maintaining QS policies, standards operating procedures and related documentation/records for the QS functions/activities
- 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
- Overseeing the performance and effectiveness of the QMS programs, as well as supporting Quality Risk Management, Training, Documentation 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 GMP inspections and audits from both regulatory authorities and partners 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

**Required qualifications and experience**
- Bachelor's or Master's degree in a relevant scientific or engineering discipline and 8+ years of industry experience within biotechnology, pharmaceuticals, or life sciences
- 5+ years of quality system management experience in a GxP regulated environment
- 2+ years experience building, leading and developing teams within quality systems
- 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 solutions
- Proactive in identifying opportunities for improvement along with strong problem-solving skills
- Experience in GMP manufacturing, and testing requirements for biologics, including aseptic technique/operations, environmental monitoring programs, and media simulation studies
- 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 with MS Office (e.g. Word, Excel, Visio, Project) and with Quality Systems (e.g. eQMS, QRM e-system, eDMS,)

**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, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You'll join a diverse and multi-disciplinary team of biol

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