Clinical Quality Manager

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 are looking for a highly motivated Clinical Quality Manager that is excited to make a positive impact on clinical trial delivery and quality for innovative new drugs. You will support internal and external project teams to ensure appropriate risk management, process improvement, and contribute to building a compliance culture. You are pivotal in driving quality and compliance in support of international clinical trial activities and ensure trials are being conducted in accordance with current ICH-GCP and regulations.

How you might spend your days

• Writing and reviewing SOPs and procedures in support of Phase 1-3 clinical trial activities, collaborating closely with Clinical Operations and Clinical Development teammates
• Assessing the impact of new or updated ICH or local guidelines on current clinical trial activities worldwide
• Performing qualifications of service providers for clinical trials and preclinical activities
• Ensuring GCP inspection readiness and preparing and assisting in the conduct of Health Authority inspections
• Overseeing CAPA to ensure timely resolution, identifying process improvements opportunities, and developing quality control plan for site quality control visits
• Executing risk-based Quality Control (QC) oversight of internal operations, ensuring alignment with the Quality Plan and study-specific deliverables, including Study Plans and Lab Manuals
• Performing regular QC of internal processes and study specific materials such as monitoring plans, pharmacy lab manuals, and advertisements
• Supporting internal project teams with understanding and interpreting ICH-GCP, regulations, SOPs, and local processes, and proactively identifying training gaps
• Maintaining and delivering training curricula (e.g., SOPs, ICH-GCP and regulations) and training compliance for internal and external stakeholders
• Providing insight on the feasibility and implementation of patient centric initiatives

We'd love to hear from you if

• You have 8+ years of relevant work experience, including 3+ years in a Clinical Quality role and proven expertise in quality control, trainings, metrics, and process improvement; experience within clinical operations would be an asset
• You are able to travel up to 20% to the sites of service providers, and are excited to collaborate with teammates across sites
• You have a Bachelor’s or post-secondary degree in Pharmaceutical Science or related field, and expertise in ICH-GCP guidelines and regulations
• You are an outstanding team player and communicator; bilingualism in French and English is strongly preferred

What we offer

AbCellera’s hiring range for this role is CAD $126,400 - $158,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.

You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials.

About AbCellera

Creating medicines is the most important work we can do.

We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline.

Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.

We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience.

We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines.

To apply

Please submit your application through our website and refer to Job ID 23352 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.